FDA PRODUCT CODE · CLASS II
OEQ — Angiography/Angioplasty Kit
This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
What these counts are not
Clearance and recall counts are SPEQ’s aggregation of FDA’s own published records for the code. A recall count is a measure of history, not of a device’s safety, neither number is an FDA rating, and SPEQ is not affiliated with the FDA.
What this classification requires
Every statement below is FDA’s own classification record for this product code, quoted from the device classification field reference. The SPEQ reading beneath each one is SPEQ’s interpretation of what it means for the work, and is not FDA text.
FDA publishes no definition for this value in the device classification field reference, so SPEQ does not interpret it.
Class II (moderate to high risk): general controls and special controls
SPEQ READINGSpecial controls are the distinguishing feature: performance standards, guidance documents, patient registries or postmarket surveillance named for the device type. Find the special controls before designing the test plan — they usually name the tests.
Device is eligible for The Voluntary Malfunction Summary Reporting Program
SPEQ READINGMalfunctions for this code may be reported in periodic summary form rather than as individual MDRs under 21 CFR Part 803. Eligibility is a property of the product code; using it is a decision the manufacturer makes and must be able to justify.
Not exempt due to Good Manufacturing Practice (GMP)/Quality System
SPEQ READINGThe full Quality Management System Regulation (21 CFR 820, incorporating ISO 13485:2016) applies, and is what an FDA inspection of this device will be conducted against.
Device is not implantable
SPEQ READINGNo implant-specific expectations attach from the classification itself.
Device is not used for life sustaining purposes
SPEQ READINGNo life-sustaining designation attaches to this code.
Device is not a candidate for a third party review program
SPEQ READINGFDA reviews any premarket notification for this code directly.
Other product codes under 21 CFR 870.1650
One regulation usually governs several product codes. These share this code’s regulation, and therefore its classification basis.
21 CFR 870.1650 — Angiographic injector and syringe
The classification regulation for this product code, as published by the Office of the Federal Register. This is the regulation text itself — no SPEQ interpretation appears in it.
(a) Identification. An angiographic injector and syringe is a device that consists of a syringe and a high-pressure injector which are used to inject contrast material into the heart, great vessels, and coronary arteries to study the heart and vessels by x-ray photography.
(b) Classification. Class II (special controls). The device, when it is a non-patient contacting balloon inflation syringe intended only to inflate/deflate balloon catheters and monitor pressure within the balloon, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9. [45 FR 7907, Feb. 5, 1980, as amended at 84 FR 71811, Dec. 30, 2019]
Source: Electronic Code of Federal Regulations, Title 21. 21 CFR is a work of the United States Government and is in the public domain. SPEQ read this section on October 21, 2026. CFR is amended continuously, so verify against the source before acting on it: read 21 CFR 870.1650 on eCFR →
Recent recalls
Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.
Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness can
It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.
Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which could lead to infection.
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
Source: FDA device classification, 510(k)/PMA, and recall datasets. Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. Browse every product code SPEQ tracks →