Impra, Inc.: FDA filings under this applicant name
FDA lists 29 510(k) clearances under the applicant name “Impra, Inc.” (first 1979, latest 2001), across 11 product codes in 3 review panels. Median 510(k) review time under this name: 88 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DSY | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter | 10 | 10 |
| DYF | Prosthesis, Vascular Graft, Of Less Then 6mm Diameter | 6 | 6 |
| CAC | Apparatus, Autotransfusion | 4 | 4 |
| LFJ | Catheter, Subclavian | 2 | 2 |
| CAR | Monitor, Spinal-Fluid Pressure, Electrically Powered | 1 | 1 |
| DQY | Catheter, Percutaneous | 1 | 1 |
| DRE | Dilator, Vessel, For Percutaneous Catheterization | 1 | 1 |
| DXE | Catheter, Embolectomy | 1 | 1 |
| DXZ | Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene | 1 | 1 |
| FKX | System, Peritoneal, Automatic Delivery | 1 | 1 |
Plus 1 more product codes.
Review panels
Most recent Impra, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K004012 | IMPRA CARBOFLO EPTFE VASCULAR GRAFTS | DYF | 2001-05-14 | 138 |
| K004011 | IMPRA CARBOFLO VASCULAR GRAFT, IMPRA CARBOFLO VASCULAR GRAFTS FOR A-V ACCESS | DSY | 2001-03-27 | 90 |
| K991027 | BI-DIRECTIONAL TUNNELER | DSY | 1999-04-22 | 24 |
| K983769 | DISTAFLO BYPASS GRAFT | DYF | 1998-12-15 | 50 |
| K983861 | DISTAFLO BYPASS GRAFT | DSY | 1998-11-24 | 22 |
| K983064 | IMPRA HIGH POROSITY GRAFT | DSY | 1998-11-19 | 78 |
| K981079 | VENAFLO PTFE VASCULAR GRAFT, VENAFLO GRAFT WITH CARBON, VENAFLO VASCULAR GRAFT | DSY | 1998-05-07 | 44 |
| K981076 | VENAFLO PTFE VASCULAR GRAFT, VENAFLO GRAFT WITH CARBON, VENAFLO VASCULAR GRAFT | DYF | 1998-05-07 | 44 |
| K971192 | IMPRA EPTFE ARTERIOVENOUS CUFFED GRAFT | DSY | 1997-04-15 | 15 |
| K964877 | IMPRA EPTFE ARTERIOVENOUS CUFFED GRAFT | DYF | 1997-03-20 | 105 |
19 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Impra, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Impra, Inc.?
FDA lists 29 510(k) clearances under the applicant name “Impra, Inc.” (first 1979, latest 2001), across 11 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Impra, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Impra, Inc. is 88 days.
Which FDA product codes appear under Impra, Inc.?
The most frequent FDA product codes under this applicant name are DSY (Prosthesis, Vascular Graft, Of 6mm And Greater Diameter, 10); DYF (Prosthesis, Vascular Graft, Of Less Then 6mm Diameter, 6); CAC (Apparatus, Autotransfusion, 4).
Next steps
- See all 29 Impra, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DSY, Impra, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.