Prosthesis, Vascular Graft, Of Less Then 6mm Diameter
The Small-Diameter Vascular Graft Prosthesis (less than 6 mm internal diameter) is a cardiovascular implant used to replace or bypass narrowed or damaged blood vessels in peripheral or coronary vascular surgery where native vessels of sufficient size are unavailable. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) clearance before marketing. The product code is DYF and the applicable regulation is 21 CFR 870.3450, under the Cardiovascular medical specialty. This device is an implant.
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Basic Information
- Product Code
- DYF
- Device Class
- FDA class 2
- Regulation Number
- 870.3450
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 21 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K004012 | IMPRA CARBOFLO EPTFE VASCULAR GRAFTS | May 14, 2001 | Substantially Equivalent | Impra, Inc. |
| K000504 | ADVANTA SUPER SOFT GRAFT | Mar 01, 2000 | Substantially Equivalent | Atrium Medical Corp. |
| K992958 | ADVANTA GRAFT (<6MM) | Oct 01, 1999 | Substantially Equivalent | Atrium Medical Corp. |
| K991683 | PTFE RINGED GORE-TEX VASCULAR GRAFT | Sep 08, 1999 | Substantially Equivalent | W. L. Gore & Associates, Inc. |
| K992441 | ADVANTA GRAFT | Aug 20, 1999 | Substantially Equivalent | Atrium Medical Corp. |
| K984183 | PERMA-PASS VASCULAR GRAFT, 5T GRAFT,MODEL 31451 | Feb 01, 1999 | Substantially Equivalent | Possis Medical, Inc. |
| K983769 | DISTAFLO BYPASS GRAFT | Dec 15, 1998 | Substantially Equivalent | Impra, Inc. |
| K981076 | VENAFLO PTFE VASCULAR GRAFT, VENAFLO GRAFT WITH CARBON, VENAFLO VASCULAR GRAFT | May 07, 1998 | Substantially Equivalent | Impra, Inc. |
| K964877 | IMPRA EPTFE ARTERIOVENOUS CUFFED GRAFT | Mar 20, 1997 | Substantially Equivalent - Subject to Tracking Reg. | Impra, Inc. |
| K960766 | MEADOX MEDICALS, INC. EXPANDED PTFE VASCULAR GRAFT | Mar 19, 1997 | Substantially Equivalent - Subject to Tracking Reg. | Meadox Medicals, Div. Boston Scientific Corp. |
| K955533 | DIASTAT VASCULAR ACCESS GRAFT | May 15, 1996 | Substantially Equivalent - Subject to Tracking Reg. | W. L. Gore & Associates, Inc. |
| K953287 | DIASTAT VASCULAR ACCESS GRAFT | Oct 06, 1995 | Substantially Equivalent - Subject to Tracking Reg. | W. L. Gore & Associates, Inc. |
| K944844 | BAXTER REINFORCED EXPANDED PTFE STEPPED VASCULAR GRAFT | Mar 31, 1995 | Unknown | Baxter Healthcare Corp |
| K933391 | ATRIUM'S HYBRID PTFE | Dec 15, 1994 | Unknown | Atrium Medical Corp. |
| K940824 | DIASTAT(TM) VASCULAR ACCESS GRAFT/CLASS III | May 04, 1994 | Substantially Equivalent - Subject to Tracking & PMS | W. L. Gore & Associates, Inc. |
| K934726 | FEP RINGED GORE-TEX VASCULAR GRAFT | Dec 08, 1993 | Substantially Equivalent | W. L. Gore & Associates, Inc. |
| K924360 | IMPRA FLEX GRAFTS (VARIOUS PRODUCT CODE NUMBERS) | Nov 25, 1992 | Unknown | Impra, Inc. |
| K881732 | GORE-TEX VASCULAR GRAFT | May 18, 1988 | Substantially Equivalent | W. L. Gore & Associates, Inc. |
| K842144 | GORE-TEX VASCULAR GRAFT, FEP-RINGED | Oct 01, 1984 | Substantially Equivalent | W. L. Gore & Associates, Inc. |
| K821826 | FEP-RINGED GORE-TEX@ VASCULAR GRAFT | Dec 29, 1982 | Substantially Equivalent | W. L. Gore & Associates, Inc. |
| K791810 | VASCULAR GRAFT PROST. OF EXPANDED PTFE | Oct 09, 1979 | Substantially Equivalent | Impra, Inc. |
FEI Numbers
This FDA classification entry is associated with 8 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 8 registration numbers. Click on an entry to view related FDA registrations.