Bio-Vascular, Inc.: FDA filings under this applicant name
FDA lists 26 510(k) clearances under the applicant name “Bio-Vascular, Inc.” (first 1986, latest 2000), across 12 product codes in 6 review panels. Median 510(k) review time under this name: 79 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 |
|---|---|---|---|
| FTM | Mesh, Surgical | 7 | 7 |
| DXZ | Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene | 4 | 4 |
| DXC | Clamp, Vascular | 3 | 3 |
| GXQ | Dura Substitute | 3 | 3 |
| DWP | Dilator, Vessel, Surgical | 2 | 2 |
| DTR | Heat-Exchanger, Cardiopulmonary Bypass | 1 | 1 |
| DWS | Instruments, Surgical, Cardiovascular | 1 | 1 |
| FTL | Mesh, Surgical, Polymeric | 1 | 1 |
| HQX | Implant, Orbital, Extra-Ocular | 1 | 1 |
| LLZ | System, Image Processing, Radiological | 1 | 1 |
Plus 2 more product codes.
Review panels
- Cardiovascular (11)
- General and Plastic Surgery (8)
- Neurology (3)
- Ophthalmic (2)
- Obstetrics and Gynecology (1)
- Radiology (1)
Most recent Bio-Vascular, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K002233 | BVI SLING | PAJ | 2000-10-13 | 81 |
| K992537 | PERI-STRIPS-SLEEVE, PERI-STRIPS-STRIP AND PERI-STRIPS DRY (NON-NAOH-TREATED AND NAOH-TREATED | FTM | 2000-02-22 | 208 |
| K983602 | CV PERI-GUARD AND VASCU-GUARD | DXZ | 1998-11-12 | 30 |
| K983581 | OCU-GUARD AND OCU-GUARD SUPPLE | HQX | 1998-11-06 | 24 |
| K983162 | PERI-GUARD, CV PERI-GUARD, OCU-GUARD, SUPPLE PERI-GUARD, PERI-STRIPS - SLEEVE, PERI-STRIPS-STRIPS, PERI-STRIPS DRY, VASC | FTM | 1998-10-09 | 29 |
| K981624 | FLO-THRU | DXC | 1998-08-04 | 89 |
| K982282 | DURA-GUARD - DURAL REPAIR PATCH | GXQ | 1998-07-30 | 30 |
| K971726 | CV PERI-GUARD - CARDIOVASCULAR PATCH | DXZ | 1998-04-10 | 336 |
| K973706 | DURA-GUARD-DURAL REPAIR PATCH | GXQ | 1997-12-24 | 86 |
| K973552 | OCU-GUARD ORBITAL IMPLANT WRAP, SUPPLE OCU-GUARD ORBITAL IMPLANT WRAP | MTZ | 1997-12-16 | 88 |
16 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Bio-Vascular, 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 Bio-Vascular, Inc.?
FDA lists 26 510(k) clearances under the applicant name “Bio-Vascular, Inc.” (first 1986, latest 2000), across 12 product codes in 6 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 Bio-Vascular, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Bio-Vascular, Inc. is 79 days.
Which FDA product codes appear under Bio-Vascular, Inc.?
The most frequent FDA product codes under this applicant name are FTM (Mesh, Surgical, 7); DXZ (Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene, 4); DXC (Clamp, Vascular, 3).
Next steps
- See all 26 Bio-Vascular, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FTM, Bio-Vascular, 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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.