# K993667: Sulzer Vascutek Sealptfe Vascular Prosthesis

- Pathway: 510(k) (Traditional)
- Applicant: Sulzermedica
- Decided: Jan 28, 2000 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.
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. The FDA summary names its predicate without a number.
- (no number) Impra commercial grafts: named in the summary without a submission number

## Indications for use
Sulzer Vascutek SEALPTFE™ grafts are intended for the creation of subcutaneous arteriovenous conduits for blood access, bypass, or reconstruction of occluded or diseased arterial blood vessels. Typical applications for standard wall grafts include systemic vascular repair, primarily for axillo-femoral/bifemoral bypass and femoral-popliteal reconstruction. Typical applications for thin wall grafts include systemic vascular repair, but not for axillo-femoral/bifemoral bypass reconstruction.

Source page: https://510kreport.com/device/K993667
Methodology: https://510kreport.com/methodology