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DYF — Prosthesis, Vascular Graft, Of Less Then 6mm Diameter Class II

FDA Device Classification

Classification Details

Product Code
DYF
Device Class
Class II
Regulation Number
870.3450
Submission Type
Review Panel
CV
Medical Specialty
Cardiovascular
Implant
Yes

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K004012impraIMPRA CARBOFLO EPTFE VASCULAR GRAFTSMay 14, 2001
K000504atrium medicalADVANTA SUPER SOFT GRAFTMarch 1, 2000
K992958atrium medicalADVANTA GRAFT (<6MM)October 1, 1999
K991683w.l. gore and associatesPTFE RINGED GORE-TEX VASCULAR GRAFTSeptember 8, 1999
K992441atrium medicalADVANTA GRAFTAugust 20, 1999
K984183possis medicalPERMA-PASS VASCULAR GRAFT, 5T GRAFT,MODEL 31451February 1, 1999
K983769impraDISTAFLO BYPASS GRAFTDecember 15, 1998
K981076impraVENAFLO PTFE VASCULAR GRAFT, VENAFLO GRAFT WITH CARBON, VENAFLO VASCULAR GRAFTMay 7, 1998
K964877impraIMPRA EPTFE ARTERIOVENOUS CUFFED GRAFTMarch 20, 1997
K960766meadox medicals, div. boston scientificMEADOX MEDICALS, INC. EXPANDED PTFE VASCULAR GRAFTMarch 19, 1997
K955533w.l. gore and associatesDIASTAT VASCULAR ACCESS GRAFTMay 15, 1996
K953287w.l. gore and associatesDIASTAT VASCULAR ACCESS GRAFTOctober 6, 1995
K944844baxter healthcareBAXTER REINFORCED EXPANDED PTFE STEPPED VASCULAR GRAFTMarch 31, 1995
K933391atrium medicalATRIUM'S HYBRID PTFEDecember 15, 1994
K940824w.l. gore and associatesDIASTAT(TM) VASCULAR ACCESS GRAFT/CLASS IIIMay 4, 1994
K934726w.l. gore and associatesFEP RINGED GORE-TEX VASCULAR GRAFTDecember 8, 1993
K924360impraIMPRA FLEX GRAFTS (VARIOUS PRODUCT CODE NUMBERS)November 25, 1992
K881732w.l. gore and associatesGORE-TEX VASCULAR GRAFTMay 18, 1988
K842144w.l. gore and associatesGORE-TEX VASCULAR GRAFT, FEP-RINGEDOctober 1, 1984
K821826w.l. gore and associatesFEP-RINGED GORE-TEX@ VASCULAR GRAFTDecember 29, 1982