DISTAFLO BYPASS GRAFT
FDA 510(k) clearance K983861 · decided 1998-11-24
Clearance details
- K-number
- K983861
- Device name
- DISTAFLO BYPASS GRAFT
- Applicant
- Impra, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1998-11-02
- Decision date
- 1998-11-24
- Days to decision
- 22 days
- Clearance type
- Abbreviated
- Product code
- DSY
- Device class
- 2
- Regulation number
- 870.3450
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Tempe, AZ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Bard Distaflo Vascular Bypass Graft; Product Code: DF6006SC; 8 mm x 60 cm. Intended for by recall (Z-0785-2016) | Bard Peripheral Vascular Inc | 2016-02-09 |
| Bard Distaflo Vascular Bypass Graft; Product Code: DF8006SC; 6 mm x 80 cm. Intended for by recall (Z-0786-2016) | Bard Peripheral Vascular Inc | 2016-02-09 |