FDA PRODUCT CODE · CLASS III
NIP — Stent, Superficial Femoral Artery
Stent, Superficial Femoral Artery -- a metal scaffold placed via a delivery catheter into the superficial femoral artery artery to maintain the lumen
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.
PMA
SPEQ READINGPremarket approval under 21 CFR Part 814. FDA reviews safety and effectiveness directly rather than by comparison, so clinical evidence is normally expected and the quality system is inspected before approval rather than after marketing.
Class III (high risk): general controls and Premarket Approval (PMA)
SPEQ READINGGeneral controls are insufficient to assure safety and effectiveness, so approval rests on direct evidence rather than equivalence.
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 implantable
SPEQ READINGImplant status raises the evidentiary bar on biocompatibility and on traceability from finished device back to material lot.
Device is used for life sustaining purposes.
SPEQ READINGA life-sustaining designation is what brings device tracking under 21 CFR Part 821 into scope, and it raises what a risk file has to say about single-fault conditions.
Device is not a candidate for a third party review program
SPEQ READINGFDA reviews any premarket notification for this code directly.
Recent clearances
Recent recalls
Seal defects could compromise the ability of the product packaging to maintain sterility.
Stent possibly unable to be fully released from the delivery system.
Stent possibly unable to be fully released from the delivery system.
Bard Peripheral Vascular is recalling specific lots of Bard Lifestent Solo Vascular Stent because they have determined a higher incidence rate of partial stent deployment associated with their use.
During recent routine testing, the MISAGO Peripheral Stent was found not to conform to product specification related to stent diameter at the proximal/distal ends and/or the shape of the stent.
Stent length on the label may not match the length of the stent itself.
Cordis has initiated a labeling correction for S.M.A.R.T. and PRECISE stents due to incorrect MRI information on the IFU. The correct classification is "MRI Conditional" not "MRI Safe".
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 →