Bio-Vascular, Inc.
St. Paul, MN, US
Bio-Vascular, Inc. appears in FDA device records in St. Paul, MN. FDA records list 26 510(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
- 26
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 26 510(k) clearances for Bio-Vascular, Inc. between 1986 and 2000. The busiest year on record is 1998, with 6. The most recent is 2000, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1986 | 1 |
| 1988 | 1 |
| 1990 | 1 |
| 1991 | 2 |
| 1992 | 2 |
| 1994 | 4 |
| 1995 | 1 |
| 1996 | 3 |
| 1997 | 3 |
| 1998 | 6 |
| 2000 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K002233 | BVI SLING | PAJ | Substantially Equivalent | |
| K992537 | PERI-STRIPS-SLEEVE, PERI-STRIPS-STRIP AND PERI-STRIPS DRY (NON-NAOH-TREATED AND NAOH-TREATED | FTM | Substantially Equivalent | |
| K983602 | CV PERI-GUARD AND VASCU-GUARD | DXZ | Substantially Equivalent | |
| K983581 | OCU-GUARD AND OCU-GUARD SUPPLE | HQX | Substantially Equivalent | |
| K983162 | PERI-GUARD, CV PERI-GUARD, OCU-GUARD, SUPPLE PERI-GUARD, PERI-STRIPS - SLEEVE, PERI-STRIPS-STRIPS, PERI-STRIPS DRY, VASC | FTM | Substantially Equivalent | |
| K981624 | FLO-THRU | DXC | Substantially Equivalent | |
| K982282 | DURA-GUARD - DURAL REPAIR PATCH | GXQ | Substantially Equivalent | |
| K971726 | CV PERI-GUARD - CARDIOVASCULAR PATCH | DXZ | Substantially Equivalent | |
| K973706 | DURA-GUARD-DURAL REPAIR PATCH | GXQ | Substantially Equivalent | |
| K973552 | OCU-GUARD ORBITAL IMPLANT WRAP, SUPPLE OCU-GUARD ORBITAL IMPLANT WRAP | MTZ | Substantially Equivalent | |
| K971048 | PERI-STRIPS DRY - STAPLE LINE REINFORCEMENT | FTM | Substantially Equivalent | |
| K963697 | ADVANCED DIAGNOSTIC VIEWER (ADV) | LLZ | Substantially Equivalent | |
| K961811 | PERI-GUARD PERICARDIUM | FTM | Substantially Equivalent | |
| K961810 | SUPPLE PERI-GUARD PERICARDIUM | FTM | Substantially Equivalent | |
| K950956 | DURA-GUARD DURAL REPAIR PATCH, DURA-GUARD DURA SUBSTITUTE | GXQ | Substantially Equivalent | |
| K942812 | FLO-RESTER DISPOSABLE VESSEL OCCLUDER | DXC | Substantially Equivalent | |
| K942583 | PERI-STRIPS PLANAR CONFIGURATION STAPLE LINE REINFORCEMENT | FTL | Substantially Equivalent | |
| K942010 | VASCU-GUARD | DXZ | Substantially Equivalent | |
| K940205 | PERI-STRIPS | FTM | Substantially Equivalent | |
| K923657 | SUPPLE PERI-GUARD | FTM | Substantially Equivalent | |
| K921895 | TISSUE PATCH, TISSUE GRAFT | DXZ | Unknown | |
| K910682 | ROBICSEK PROBE/RETRACTOR | DWP | Substantially Equivalent | |
| K905159 | FLO-RESTER(R) VESSEL SIZER | DWP | Substantially Equivalent | |
| K896307 | INSULATION PAD | DWS | Substantially Equivalent | |
| K883696 | FLO-RESTER | DXC | Substantially Equivalent | |
| K860523 | CARDIO-COOL | DTR | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- DXCClamp, Vascular
- DWPDilator, Vessel, Surgical
- GXQDura Substitute
- DTRHeat-Exchanger, Cardiopulmonary Bypass
- HQXImplant, Orbital, Extra-Ocular
- DWSInstruments, Surgical, Cardiovascular
- FTMMesh, Surgical
- PAJMesh, Surgical, Non-Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
- FTLMesh, Surgical, Polymeric
- DXZPatch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
- LLZSystem, Image Processing, Radiological
- MTZWrap, Implant, Orbital
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