510(k) K940824
- Device
- DIASTAT(TM) VASCULAR ACCESS GRAFT/CLASS III
- Applicant
- W.L. GORE & ASSOCIATES,INC
- 510(k) number
- K940824
- Product code
- DYF
- Decision
- Se Subject To Traking & Pms (PT)
- Decision date
- 1994-05-04
- Date received
- 1994-01-06
- Regulation
- 870.3450
- Classification name
- Prosthesis, Vascular Graft, Of Less Then 6mm Diameter
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- JAMES D LEWIS
- Address
- 1505 N. Fourth St. P.O. Box 2200 Flagstaff AZ US 86003 86003
FDA Registration Numbers#
- 3013718163
- 1220477
- 2020394
- 3006082230
- 1018233
- 2017233
- 2242352
- 3011175548
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code DYF #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K004012 | IMPRA CARBOFLO EPTFE VASCULAR GRAFTS | Impra, Inc. | 2001-05-14 |
| K000504 | ADVANTA SUPER SOFT GRAFT | Atrium Medical Corp. | 2000-03-01 |
| K992958 | ADVANTA GRAFT (<6MM) | Atrium Medical Corp. | 1999-10-01 |
| K991683 | PTFE RINGED GORE-TEX VASCULAR GRAFT | W. L. Gore & Associates, Inc. | 1999-09-08 |
| K992441 | ADVANTA GRAFT | Atrium Medical Corp. | 1999-08-20 |
| K984183 | PERMA-PASS VASCULAR GRAFT, 5T GRAFT,MODEL 31451 | Possis Medical, Inc. | 1999-02-01 |
| K983769 | DISTAFLO BYPASS GRAFT | Impra, Inc. | 1998-12-15 |
| K981076 | VENAFLO PTFE VASCULAR GRAFT, VENAFLO GRAFT WITH CARBON, VENAFLO VASCULAR GRAFT | Impra, Inc. | 1998-05-07 |
| K964877 | IMPRA EPTFE ARTERIOVENOUS CUFFED GRAFT | Impra, Inc. | 1997-03-20 |
| K960766 | MEADOX MEDICALS, INC. EXPANDED PTFE VASCULAR GRAFT | Meadox Medicals, Div. Boston Scientific Corp. | 1997-03-19 |
| K955533 | DIASTAT VASCULAR ACCESS GRAFT | W. L. Gore & Associates, Inc. | 1996-05-15 |
| K953287 | DIASTAT VASCULAR ACCESS GRAFT | W. L. Gore & Associates, Inc. | 1995-10-06 |
| K944844 | BAXTER REINFORCED EXPANDED PTFE STEPPED VASCULAR GRAFT | Baxter Healthcare Corp | 1995-03-31 |
| K933391 | ATRIUM'S HYBRID PTFE | Atrium Medical Corp. | 1994-12-15 |
| K934726 | FEP RINGED GORE-TEX VASCULAR GRAFT | W. L. Gore & Associates, Inc. | 1993-12-08 |
Legacy Summary#
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FDA Review#
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