← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

OMF — Percutaneous, Implanted, Long-Term Intravascular Catheter Accessory For Catheter Position

When used in connection with a locator instrument is designed to aid in the placement of central venous catheters by providing real-time information as to the position of the catheter inside the body during the catheter insertion procedure.

DEVICE CLASS
Class II
REGULATION
21 CFR 880.5970
MEDICAL SPECIALTY
General Hospital
REVIEW PANEL
HO
✓ Implant— Life-sustaining— GMP-exempt— Third-party review eligible
0
510(K)/PMA CLEARANCES
0
RECALL ENTRIES

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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