← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS III

NIPStent, 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

DEVICE CLASS
Class III
MEDICAL SPECIALTY
Unknown
REVIEW PANEL
CV
ImplantLife-sustainingGMP-exemptThird-party review eligible
10
510(K)/PMA CLEARANCES
pma: 10
0
RECALL ENTRIES

Recent clearances

P110023Medtronic Vascular, Inc. · pma2026-07-10
P160025Biotronik AG · pma2026-06-22
P070014Bard Peripheral Vascular, Inc. · pma2026-06-10
P040037W. L. Gore & Associates, Inc. · pma2026-05-26
P140028Boston Scientific Corporation · pma2026-05-06
P120020Abbott Vascular (Idef Technologies Inc) · pma2026-03-20
P180003Veryan Medical, Ltd. · pma2026-02-19
P140002Terumo Medical Corporation · pma2026-02-13

Related on SPEQ

Medical devices industryMedical device quality (ISO 13485)FDA device clearancesFDA 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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