Atlas FDA

DYF

21 FDA 510(k) clearances · Product code

89 daysmedian time to decision
190 days90th percentile
21clearances measured

FDA profile

Official device name
Prosthesis, Vascular Graft, Of Less Then 6mm Diameter
Device class
Class II (moderate risk)
Regulation
21 CFR 870.3450
Medical specialty
Cardiovascular
Flags
Implant
Adverse events (MAUDE)
2011: 9 · 2013: 16 · 2014: 7 · 2015: 12 · 2016: 35 · 2017: 18
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
IMPRA CARBOFLO EPTFE VASCULAR GRAFTS (K004012)Impra, Inc.2001-05-14
ADVANTA SUPER SOFT GRAFT (K000504)Atrium Medical Corp.2000-03-01
ADVANTA GRAFT (<6MM) (K992958)Atrium Medical Corp.1999-10-01
PTFE RINGED GORE-TEX VASCULAR GRAFT (K991683)W. L. Gore & Associates, Inc.1999-09-08
ADVANTA GRAFT (K992441)Atrium Medical Corp.1999-08-20
PERMA-PASS VASCULAR GRAFT, 5T GRAFT,MODEL 31451 (K984183)Possis Medical, Inc.1999-02-01
DISTAFLO BYPASS GRAFT (K983769)Impra, Inc.1998-12-15
VENAFLO PTFE VASCULAR GRAFT, VENAFLO GRAFT WITH CARBON, VENAFLO VASCULAR GRAFT (K981076)Impra, Inc.1998-05-07
IMPRA EPTFE ARTERIOVENOUS CUFFED GRAFT (K964877)Impra, Inc.1997-03-20
MEADOX MEDICALS, INC. EXPANDED PTFE VASCULAR GRAFT (K960766)Meadox Medicals, Div. Boston Scientific Corp.1997-03-19
DIASTAT VASCULAR ACCESS GRAFT (K955533)W. L. Gore & Associates, Inc.1996-05-15
DIASTAT VASCULAR ACCESS GRAFT (K953287)W. L. Gore & Associates, Inc.1995-10-06
BAXTER REINFORCED EXPANDED PTFE STEPPED VASCULAR GRAFT (K944844)Baxter Healthcare Corp1995-03-31
ATRIUM'S HYBRID PTFE (K933391)Atrium Medical Corp.1994-12-15
DIASTAT(TM) VASCULAR ACCESS GRAFT/CLASS III (K940824)W. L. Gore & Associates, Inc.1994-05-04
FEP RINGED GORE-TEX VASCULAR GRAFT (K934726)W. L. Gore & Associates, Inc.1993-12-08
IMPRA FLEX GRAFTS (VARIOUS PRODUCT CODE NUMBERS) (K924360)Impra, Inc.1992-11-25
GORE-TEX VASCULAR GRAFT (K881732)W. L. Gore & Associates, Inc.1988-05-18
GORE-TEX VASCULAR GRAFT, FEP-RINGED (K842144)W. L. Gore & Associates, Inc.1984-10-01
FEP-RINGED GORE-TEX@ VASCULAR GRAFT (K821826)W. L. Gore & Associates, Inc.1982-12-29
VASCULAR GRAFT PROST. OF EXPANDED PTFE (K791810)Impra, Inc.1979-10-09

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Every clearance here is in the API, with alerts when new ones post.