# P000033: Intra Coil Self-Expanding Peripheral Stent

- Pathway: PMA
- Applicant: Medtronic Vascular, Inc.
- Decided: Apr 3, 2002 after 608 days
- Product code: NIP (Stent, Superficial Femoral Artery)
- Device class: 3
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Recalls of this device
- Apr 9, 2008 · Not classified · Z-1816-2008: An IntraCoil 6 mm x 40 mm stent was labeled as a 6 mm x 60 mm stent.
- Apr 2, 2008 · Not classified · Z-1815-2008: Incorrect Label - an IntraCoil 5mm x 40 mm stent was labeled as a 5 mm x 60 mm stent (VT-5-40-135 was labeled as VT-5-60-135).

Source page: https://510kreport.com/device/P000033
Methodology: https://510kreport.com/methodology