Product code DYF— Cardiovascular
DIASTAT VASCULAR ACCESS GRAFT
- Classification name
- Prosthesis, Vascular Graft, Of Less Then 6mm Diameter
- Device class
- Class 2
- Regulation
- 21 CFR 870.3450
- Advisory panel
- Cardiovascular
- Total cleared
- 21
- First cleared
- Most recent
Market context for product code DYF
FDA has cleared devices under product code DYF between 1979 and 2001, filed by 6 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2001
- 2000
- 1999
- 1998
- 1997
- 1996
- 1995
- 1994
- 1993
- 1992
- 1988
- 1984
- 1982
- 1979
Top applicants under product code DYF
Recent clearances under product code DYF
- K004012 — IMPRA CARBOFLO EPTFE VASCULAR GRAFTS
- K000504 — ADVANTA SUPER SOFT GRAFT
- K992958 — ADVANTA GRAFT (<6MM)
- K991683 — PTFE RINGED GORE-TEX VASCULAR GRAFT
- K992441 — ADVANTA GRAFT
- K984183 — PERMA-PASS VASCULAR GRAFT, 5T GRAFT,MODEL 31451
- K983769 — DISTAFLO BYPASS GRAFT
- K981076 — VENAFLO PTFE VASCULAR GRAFT, VENAFLO GRAFT WITH CARBON, VENAFLO VASCULAR GRAFT
- K964877 — IMPRA EPTFE ARTERIOVENOUS CUFFED GRAFT
- K960766 — MEADOX MEDICALS, INC. EXPANDED PTFE VASCULAR GRAFT
- K955533 — DIASTAT VASCULAR ACCESS GRAFT
- K953287 — DIASTAT VASCULAR ACCESS GRAFT
- K944844 — BAXTER REINFORCED EXPANDED PTFE STEPPED VASCULAR GRAFT
- K933391 — ATRIUM'S HYBRID PTFE
- K940824 — DIASTAT(TM) VASCULAR ACCESS GRAFT/CLASS III
- K934726 — FEP RINGED GORE-TEX VASCULAR GRAFT
- K924360 — IMPRA FLEX GRAFTS (VARIOUS PRODUCT CODE NUMBERS)
- K881732 — GORE-TEX VASCULAR GRAFT
- K842144 — GORE-TEX VASCULAR GRAFT, FEP-RINGED
- K821826 — FEP-RINGED GORE-TEX@ VASCULAR GRAFT
- K791810 — VASCULAR GRAFT PROST. OF EXPANDED PTFE
Data sourced from openFDA. This site is unofficial and independent of the FDA.