# K983861: Distaflo Bypass Graft

- Pathway: 510(k) (Abbreviated)
- Applicant: Impra, Inc.
- Decided: Nov 24, 1998 after 22 days
- Product code: DSY (Prosthesis, Vascular Graft, Of 6mm And Greater Diameter)
- Device class: 2
- Regulation: 21 CFR 870.3450
- Recalls of this device: 2 (0 Class I)
- 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; 3 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 Carboflo® Vascular Graft: named in the summary without a submission number
- (no number) Venaflo® Vascular Graft: named in the summary without a submission number

## Most influential descendants
- K050049: Dynaflo Bypass Graft (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

## Recalls of this device
- Jan 5, 2016 · Class II · Z-0786-2016: Size mislabeling; the graft is a 6 mm diameter graft when the actual packaged product is an 8 mm graft.
- Jan 5, 2016 · Class II · Z-0785-2016: Size mislabeling; the graft is labeled as a 6 mm diameter graft when the actual packaged product is an 8 mm graft.

## Indications for use
Distaflo™ Bypass Grafts are intended for bypass or reconstruction of peripheral arterial blood vessels.

Source page: https://510kreport.com/device/K983861
Methodology: https://510kreport.com/methodology