Venaflo PTFE Vascular Graft, Venaflo Graft with Carbon, Venaflo Vascular Graft
FDA 510(k) K981076 · Impra, Inc.
510(k) numberK981076
Submission
- Device name
- Venaflo PTFE Vascular Graft, Venaflo Graft with Carbon, Venaflo Vascular Graft
- Applicant
- Impra, Inc.
Tempe, AZ, US - Received
- March 24, 1998
- Decision date
- May 7, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DYF – Prosthesis, Vascular Graft, Of Less Then 6mm Diameter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.3450
- Specialty
- Cardiovascular
- Implant
- Yes
Other 510(k)s with product code DYF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K004012 | Impra Carboflo Eptfe Vascular GraftsDYF · Traditional | Impra, Inc. | 05/14/2001SE |
| K000504 | Advanta Super Soft GraftDYF · Special | Atrium Medical Corp. | 03/01/2000SE |
| K992958 | Advanta Graft (<6MM)DYF · Special | Atrium Medical Corp. | 10/01/1999SE |
| K991683 | PTFE Ringed Gore-Tex Vascular GraftDYF · Traditional | W. L. Gore & Associates, Inc. | 09/08/1999SE |
| K992441 | Advanta GraftDYF · Special | Atrium Medical Corp. | 08/20/1999SE |
| K984183 | Perma-Pass Vascular Graft, 5T Graft,Model 31451DYF · Traditional | Possis Medical, Inc. | 02/01/1999SE |
| K983769 | Distaflo Bypass GraftDYF · Abbreviated | Impra, Inc. | 12/15/1998SE |
| K964877 | Impra Eptfe Arteriovenous Cuffed GraftDYF · Traditional | Impra, Inc. | 03/20/1997ST |
| K960766 | Meadox Medicals, Inc. Expanded PTFE Vascular GraftDYF · Traditional | Meadox Medicals, Div. Boston Scientific Corp. | 03/19/1997ST |
| K955533 | Diastat Vascular Access GraftDYF · Traditional | W. L. Gore & Associates, Inc. | 05/15/1996ST |
More from W. L. Gore & Associates, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K004012 | Impra Carboflo Eptfe Vascular GraftsDYF · Traditional | 05/14/2001SE |
| K004011 | Impra Carboflo Vascular Graft, Impra Carboflo Vascular Grafts for A-V AccessDSY · Traditional | 03/27/2001SE |
| K991027 | Bi-Directional TunnelerDSY · Special | 04/22/1999SE |
| K983769 | Distaflo Bypass GraftDYF · Abbreviated | 12/15/1998SE |
| K983861 | Distaflo Bypass GraftDSY · Abbreviated | 11/24/1998SE |
| K983064 | Impra High Porosity GraftDSY · Traditional | 11/19/1998SE |
| K981079 | Venaflo PTFE Vascular Graft, Venaflo Graft with Carbon, Venaflo Vascular GraftDSY · Traditional | 05/07/1998SE |
| K971192 | Impra Eptfe Arteriovenous Cuffed GraftDSY · Traditional | 04/15/1997ST |
| K964877 | Impra Eptfe Arteriovenous Cuffed GraftDYF · Traditional | 03/20/1997ST |
| K964197 | Impra Carboflo Eptfe Vascular GraftDSY · Traditional | 01/02/1997SE |
Questions and answers
When was Venaflo PTFE Vascular Graft, Venaflo Graft with Carbon, Venaflo Vascular Graft cleared by the FDA?
Venaflo PTFE Vascular Graft, Venaflo Graft with Carbon, Venaflo Vascular Graft (K981076) received a 510(k) decision of Substantially Equivalent on May 7, 1998, 44 days after the submission was received.
What is the product code of K981076?
The FDA product code is DYF – Prosthesis, Vascular Graft, Of Less Then 6mm Diameter, a Class II (moderate risk) device regulated under 21 CFR 870.3450.