Medical Device Manufacturer · US , Mchenry , IL

Impra, Inc. - FDA 510(k) Cleared Devices

29 submissions · 24 cleared · Since 1979
29
Total
24
Cleared
0
Denied
FDA 510(k) Regulatory Record - Impra, Inc. Cardiovascular
20 devices
1-20 of 20
Cleared May 14, 2001
IMPRA CARBOFLO EPTFE VASCULAR GRAFTS
K004012 · DYF
Cardiovascular · 138d
Cleared Mar 27, 2001
IMPRA CARBOFLO VASCULAR GRAFT, IMPRA CARBOFLO VASCULAR GRAFTS FOR A-V ACCESS
K004011 · DSY
Cardiovascular · 90d
Cleared Apr 22, 1999
BI-DIRECTIONAL TUNNELER
K991027 · DSY
Cardiovascular · 24d
Cleared Dec 15, 1998
DISTAFLO BYPASS GRAFT
K983769 · DYF
Cardiovascular · 50d
Cleared Nov 24, 1998
DISTAFLO BYPASS GRAFT
K983861 · DSY
Cardiovascular · 22d
Cleared Nov 19, 1998
IMPRA HIGH POROSITY GRAFT
K983064 · DSY
Cardiovascular · 78d
Cleared May 07, 1998
VENAFLO PTFE VASCULAR GRAFT, VENAFLO GRAFT WITH CARBON, VENAFLO VASCULAR GRAFT
K981076 · DYF
Cardiovascular · 44d
Cleared May 07, 1998
VENAFLO PTFE VASCULAR GRAFT, VENAFLO GRAFT WITH CARBON, VENAFLO VASCULAR GRAFT
K981079 · DSY
Cardiovascular · 44d
Cleared Apr 15, 1997
IMPRA EPTFE ARTERIOVENOUS CUFFED GRAFT
K971192 · DSY
Cardiovascular · 15d
Cleared Mar 20, 1997
IMPRA EPTFE ARTERIOVENOUS CUFFED GRAFT
K964877 · DYF
Cardiovascular · 105d
Cleared Jan 02, 1997
IMPRA CARBOFLO EPTFE VASCULAR GRAFT
K964197 · DSY
Cardiovascular · 73d
Cleared Oct 03, 1996
IMPRA CARBOFLO EPTFE VASCULAR GRAFT
K962639 · DSY
Cardiovascular · 90d
Cleared Nov 25, 1992
IMPRA FLEX GRAFTS (VARIOUS PRODUCT CODE NUMBERS)
K924360 · DYF
Cardiovascular · 89d
Cleared Dec 20, 1991
CARDIOVASCULAR REPAIR PATCH
K905073 · DXZ
Cardiovascular · 406d
Cleared Jul 17, 1990
ARTERIAL EMBOLECTOMY CATHETER
K900311 · DXE
Cardiovascular · 176d
Cleared May 02, 1988
10 AND 12 FRENCH VESSEL DILATORS
K874738 · DRE
Cardiovascular · 166d
Cleared Oct 30, 1987
IMPRA DUAL LUMEN SUBCLAVIAN CATHETER
K872163 · DQY
Cardiovascular · 147d
Cleared Jul 19, 1983
VASCULAR GRAFT PROSTHESIS EXPANDED MICR
K830543 · DSY
Cardiovascular · 147d
Cleared Sep 09, 1980
VASCULAR GRAFT PROSTH. OF EXP. MICRO.
K801621 · DSY
Cardiovascular · 56d
Cleared Oct 09, 1979
VASCULAR GRAFT PROST. OF EXPANDED PTFE
K791810 · DYF
Cardiovascular · 25d
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