# K963611: Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek Gelsoft Patch,Vascutek Thin Wall Carotid Patch

- Pathway: 510(k) (Traditional)
- Applicant: Vascutek, Ltd.
- Decided: Nov 21, 1996 after 72 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: 1 generation back to K931386 (1993). 1 ancestor in all.
120 later devices descend from it; 4 cite it directly.
0 of 122 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K931386: Hemashield Microvel/Woven Double Velour Fabric, Meadox Medicals, Div. Boston Scientific Corp. (1993) Summary page 1.

## Most influential descendants
- K972651: IN-Sling (1997), 115 descendants of its own
- K980482: Triangle Sling (1998), 114 descendants of its own
- K002721: Ams Triangle Silicone-Coated Sling and Surgical Mesh (2000), 113 descendants of its own
- K010931: Ams Sacral Colpopexy Sling, Model 72403501 (2001), 80 descendants of its own
- K033636: Ams Large Pore Polypropylene Mesh (2003), 79 descendants of its own

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

Source page: https://510kreport.com/device/K963611
Methodology: https://510kreport.com/methodology