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Impra, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
29
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K004012IMPRA CARBOFLO EPTFE VASCULAR GRAFTSMay 14, 2001
K004011IMPRA CARBOFLO VASCULAR GRAFT, IMPRA CARBOFLO VASCULAR GRAFTS FOR A-V ACCESSMarch 27, 2001
K991027BI-DIRECTIONAL TUNNELERApril 22, 1999
K983769DISTAFLO BYPASS GRAFTDecember 15, 1998
K983861DISTAFLO BYPASS GRAFTNovember 24, 1998
K983064IMPRA HIGH POROSITY GRAFTNovember 19, 1998
K981076VENAFLO PTFE VASCULAR GRAFT, VENAFLO GRAFT WITH CARBON, VENAFLO VASCULAR GRAFTMay 7, 1998
K981079VENAFLO PTFE VASCULAR GRAFT, VENAFLO GRAFT WITH CARBON, VENAFLO VASCULAR GRAFTMay 7, 1998
K971192IMPRA EPTFE ARTERIOVENOUS CUFFED GRAFTApril 15, 1997
K964877IMPRA EPTFE ARTERIOVENOUS CUFFED GRAFTMarch 20, 1997
K964197IMPRA CARBOFLO EPTFE VASCULAR GRAFTJanuary 2, 1997
K962639IMPRA CARBOFLO EPTFE VASCULAR GRAFTOctober 3, 1996
K925827IMPRAFLO(TM) POST OPERATIVE/DRAIN/REINFUS KIT/CANIJuly 29, 1993
K924360IMPRA FLEX GRAFTS (VARIOUS PRODUCT CODE NUMBERS)November 25, 1992
K915577IMPRAFLO POSTOPERATIVE AUTOTRANSFUSION DEVICEMarch 11, 1992
K905073CARDIOVASCULAR REPAIR PATCHDecember 20, 1991
K904515IMPRAFLO 3500 SERIESDecember 4, 1990
K901232IMPRAFLO AUTOTRANSFUSION DEVICEJuly 18, 1990
K900311ARTERIAL EMBOLECTOMY CATHETERJuly 17, 1990
K901133DURACATHJune 8, 1990