510(k) K983861 ยท DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
DISTAFLO BYPASS GRAFT
| Applicant | Impra, Inc., Tempe AZ, US |
| Decision | Substantially Equivalent, Nov 24, 1998 |
| Received | Nov 2, 1998 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K983861
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 9, 2016 | Bard Peripheral Vascular Inc Bard Distaflo Vascular Bypass Graft; Product Code: DF6006SC; 8 mm x 60 cm.
Intended for bypass or reconstruction of peripheral arterial blood vessels. Terminated |
DSY | None listed |
| Feb 9, 2016 | Bard Peripheral Vascular Inc Bard Distaflo Vascular Bypass Graft; Product Code: DF8006SC; 6 mm x 80 cm.
Intended for bypass or reconstruction of peripheral arterial blood vessels. Terminated |
DSY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.