Impra, Inc.
Tempe, AZ, US
Impra, Inc. appears in FDA device records in Tempe, AZ. FDA records list 24 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 24
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 24 510(k) clearances for Impra, Inc. between 1987 and 2001. The busiest year on record is 1998, with 5. The most recent is 2001, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1987 | 1 |
| 1988 | 2 |
| 1989 | 1 |
| 1990 | 4 |
| 1991 | 1 |
| 1992 | 2 |
| 1993 | 1 |
| 1996 | 1 |
| 1997 | 3 |
| 1998 | 5 |
| 1999 | 1 |
| 2001 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K004012 | IMPRA CARBOFLO EPTFE VASCULAR GRAFTS | DYF | Substantially Equivalent | |
| K004011 | IMPRA CARBOFLO VASCULAR GRAFT, IMPRA CARBOFLO VASCULAR GRAFTS FOR A-V ACCESS | DSY | Substantially Equivalent | |
| K991027 | BI-DIRECTIONAL TUNNELER | DSY | Substantially Equivalent | |
| K983769 | DISTAFLO BYPASS GRAFT | DYF | Substantially Equivalent | |
| K983861 | DISTAFLO BYPASS GRAFT | DSY | Substantially Equivalent | |
| K983064 | IMPRA HIGH POROSITY GRAFT | DSY | Substantially Equivalent | |
| K981079 | VENAFLO PTFE VASCULAR GRAFT, VENAFLO GRAFT WITH CARBON, VENAFLO VASCULAR GRAFT | DSY | Substantially Equivalent | |
| K981076 | VENAFLO PTFE VASCULAR GRAFT, VENAFLO GRAFT WITH CARBON, VENAFLO VASCULAR GRAFT | DYF | Substantially Equivalent | |
| K971192 | IMPRA EPTFE ARTERIOVENOUS CUFFED GRAFT | DSY | Substantially Equivalent - Subject to Tracking Reg. | |
| K964877 | IMPRA EPTFE ARTERIOVENOUS CUFFED GRAFT | DYF | Substantially Equivalent - Subject to Tracking Reg. | |
| K964197 | IMPRA CARBOFLO EPTFE VASCULAR GRAFT | DSY | Substantially Equivalent | |
| K962639 | IMPRA CARBOFLO EPTFE VASCULAR GRAFT | DSY | Unknown | |
| K925827 | IMPRAFLO(TM) POST OPERATIVE/DRAIN/REINFUS KIT/CANI | CAC | Substantially Equivalent | |
| K924360 | IMPRA FLEX GRAFTS (VARIOUS PRODUCT CODE NUMBERS) | DYF | Unknown | |
| K915577 | IMPRAFLO POSTOPERATIVE AUTOTRANSFUSION DEVICE | CAR | Substantially Equivalent | |
| K905073 | CARDIOVASCULAR REPAIR PATCH | DXZ | Substantially Equivalent | |
| K904515 | IMPRAFLO 3500 SERIES | CAC | Substantially Equivalent | |
| K901232 | IMPRAFLO AUTOTRANSFUSION DEVICE | CAC | Substantially Equivalent | |
| K900311 | ARTERIAL EMBOLECTOMY CATHETER | DXE | Substantially Equivalent | |
| K901133 | DURACATH | LFJ | Substantially Equivalent | |
| K892819 | AUTOTRANSFUSION DEVICE | CAC | Substantially Equivalent | |
| K883592 | IMPRA DUAL LUMEN SUBCLAVIAN - FEMORAL CATHETER | LFJ | Unknown | |
| K874738 | 10 AND 12 FRENCH VESSEL DILATORS | DRE | Substantially Equivalent | |
| K872163 | IMPRA DUAL LUMEN SUBCLAVIAN CATHETER | DQY | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- CACApparatus, Autotransfusion
- DXECatheter, Embolectomy
- DQYCatheter, Percutaneous
- LFJCatheter, Subclavian
- DREDilator, Vessel, For Percutaneous Catheterization
- CARMonitor, Spinal-Fluid Pressure, Electrically Powered
- DXZPatch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
- DSYProsthesis, Vascular Graft, Of 6mm And Greater Diameter
- DYFProsthesis, Vascular Graft, Of Less Then 6mm Diameter
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain