# K021547: Flowline Biopore Eptfe Vascular Graft

- Pathway: 510(k) (Traditional)
- Applicant: Jotec GmbH
- Decided: Jan 24, 2003 after 259 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 ePTFE vascular grafts: named in the summary without a submission number
- (no number) Gore-Tex ePTFE vascular grafts: named in the summary without a submission number

## Indications for use
The Jotec FlowLine Bipore ePWE Vascular Graft is indicated in cases of arterial vasoreconstruction, primarily in the peripheral vascular region. It can also be used in extraanatomical reconstructions - femorofemoral and axillofemoral. Standard Wall FlowLine Bipore ePTFE Vascular Grafts are also indicated for use as arteriovenous shunt prostheses in hemodialysis.

Source page: https://510kreport.com/device/K021547
Methodology: https://510kreport.com/methodology