# K992832: Sulzer Vascutek Eptfe Vascular Prosthesis

- Pathway: 510(k) (Traditional)
- Applicant: Sulzermedica
- Decided: Nov 19, 1999 after 88 days
- Product code: DSY (Prosthesis, Vascular Graft, Of 6mm And Greater Diameter)
- Device class: 2
- Regulation: 21 CFR 870.3450
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
7 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Impra commercial grafts: named in the summary without a submission number

## Most influential descendants
- K051312: Swirlgraft Bypass and Vascular Access Grafts (2005), 5 descendants of its own
- K083169: Eptfe Slftm Spiral Vascular Graft (2009), 4 descendants of its own
- K142062: Spiral Flow Peripheral Vascular Graft (2014), 1 descendant of its own
- K094044: Spiral Laminar Flow Vascular Arteriovenous Graft (2010), 1 descendant of its own
- K252277: Spiral Laminar Flow™ Vascular Arteriovenous Graft  (AV0645) (2025), 0 descendants of its own

## Indications for use
Sulzer Vascutek ePTFE grafts are intended for the creation of subcutaneous arteriovenous conduits for blood access, bypass, or reconstruction of occluded or diseased arterial blood vessels.

Source page: https://510kreport.com/device/K992832
Methodology: https://510kreport.com/methodology