Company ยท US
Impra, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1979 to 2001. Name variants (Inc, Corp, punctuation) are merged.
29510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DSY | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter | 10 |
| DYF | Prosthesis, Vascular Graft, Of Less Then 6mm Diameter | 6 |
| CAC | Apparatus, Autotransfusion | 4 |
| LFJ | Catheter, Subclavian | 2 |
| CAR | Monitor, Spinal-Fluid Pressure, Electrically Powered | 1 |
| DQY | Catheter, Percutaneous | 1 |
| DRE | Dilator, Vessel, For Percutaneous Catheterization | 1 |
| DXE | Catheter, Embolectomy | 1 |
| DXZ | Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene | 1 |
| FKX | System, Peritoneal, Automatic Delivery | 1 |
| KNT | Tubes, Gastrointestinal (And Accessories) | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 14, 2001 | K004012 | IMPRA CARBOFLO EPTFE VASCULAR GRAFTS Impra, Inc. | DYF |
| Mar 27, 2001 | K004011 | IMPRA CARBOFLO VASCULAR GRAFT, IMPRA CARBOFLO VASCULAR GRAFTS FOR A-V ACCESS Impra, Inc. | DSY |
| Apr 22, 1999 | K991027 | BI-DIRECTIONAL TUNNELER Impra, Inc. | DSY |
| Dec 15, 1998 | K983769 | DISTAFLO BYPASS GRAFT Impra, Inc. | DYF |
| Nov 24, 1998 | K983861 | DISTAFLO BYPASS GRAFT Impra, Inc. | DSY |
| Nov 19, 1998 | K983064 | IMPRA HIGH POROSITY GRAFT Impra, Inc. | DSY |
| May 7, 1998 | K981079 | VENAFLO PTFE VASCULAR GRAFT, VENAFLO GRAFT WITH CARBON, VENAFLO VASCULAR GRAFT Impra, Inc. | DSY |
| May 7, 1998 | K981076 | VENAFLO PTFE VASCULAR GRAFT, VENAFLO GRAFT WITH CARBON, VENAFLO VASCULAR GRAFT Impra, Inc. | DYF |
| Apr 15, 1997 | K971192 | IMPRA EPTFE ARTERIOVENOUS CUFFED GRAFT Impra, Inc. | DSY |
| Mar 20, 1997 | K964877 | IMPRA EPTFE ARTERIOVENOUS CUFFED GRAFT Impra, Inc. | DYF |
| Jan 2, 1997 | K964197 | IMPRA CARBOFLO EPTFE VASCULAR GRAFT Impra, Inc. | DSY |
| Oct 3, 1996 | K962639 | IMPRA CARBOFLO EPTFE VASCULAR GRAFT Impra, Inc. | DSY |
| Jul 29, 1993 | K925827 | IMPRAFLO(TM) POST OPERATIVE/DRAIN/REINFUS KIT/CANI Impra, Inc. | CAC |
| Nov 25, 1992 | K924360 | IMPRA FLEX GRAFTS (VARIOUS PRODUCT CODE NUMBERS) Impra, Inc. | DYF |
| Mar 11, 1992 | K915577 | IMPRAFLO POSTOPERATIVE AUTOTRANSFUSION DEVICE Impra, Inc. | CAR |
| Dec 20, 1991 | K905073 | CARDIOVASCULAR REPAIR PATCH Impra, Inc. | DXZ |
| Dec 4, 1990 | K904515 | IMPRAFLO 3500 SERIES Impra, Inc. | CAC |
| Jul 18, 1990 | K901232 | IMPRAFLO AUTOTRANSFUSION DEVICE Impra, Inc. | CAC |
| Jul 17, 1990 | K900311 | ARTERIAL EMBOLECTOMY CATHETER Impra, Inc. | DXE |
| Jun 8, 1990 | K901133 | DURACATH Impra, Inc. | LFJ |
| May 22, 1989 | K892819 | AUTOTRANSFUSION DEVICE Impra, Inc. | CAC |
| Dec 8, 1988 | K883592 | IMPRA DUAL LUMEN SUBCLAVIAN - FEMORAL CATHETER Impra, Inc. | LFJ |
| May 2, 1988 | K874738 | 10 AND 12 FRENCH VESSEL DILATORS Impra, Inc. | DRE |
| Oct 30, 1987 | K872163 | IMPRA DUAL LUMEN SUBCLAVIAN CATHETER Impra, Inc. | DQY |
| Jul 19, 1983 | K830543 | VASCULAR GRAFT PROSTHESIS EXPANDED MICR Impra, Inc. | DSY |
| Jan 26, 1983 | K823857 | IMPRA PERITONEAL CATHETER Impra, Inc. | FKX |
| Sep 23, 1981 | K812427 | CARTMILL/BARRY FEEDING TUBE Impra, Inc. | KNT |
| Sep 9, 1980 | K801621 | VASCULAR GRAFT PROSTH. OF EXP. MICRO. Impra, Inc. | DSY |
| Oct 9, 1979 | K791810 | VASCULAR GRAFT PROST. OF EXPANDED PTFE Impra, Inc. | DYF |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||