# K972201: Patch,Pledget and Intracardiac,Petp,Ptfe,Polypropylene

- Pathway: 510(k) (Traditional)
- Applicant: Sulzer Carbomedics, Inc.
- Decided: Apr 14, 1998 after 307 days
- Product code: DXZ (Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene)
- Device class: 2
- Regulation: 21 CFR 870.3470
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K931386 (1993). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963611: Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek Gelsoft Patch,Vascutek Thin Wall Carotid Patch, Vascutek, Ltd. (1996) Summary page 1.

## Recalls of this device
- Jul 8, 2021 · Class II · Z-2543-2021: The devices contained the IFU for distribution to ROW (rest of world) consignees rather than U.S. consignees.

## Indications for use
Sulzer Vascutek Fluoropassiv™ Fabric is indicated for vascular patch grafting and for intracardiac patching. The Fluoropassiv™ Thin Wall Carotid Patch is, in addition, indicated for patch closure after endarterectomy, particularly of the carotid arteries.

Source page: https://510kreport.com/device/K972201
Methodology: https://510kreport.com/methodology