Company ยท US
Bio-Vascular, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1986 to 2000. Name variants (Inc, Corp, punctuation) are merged.
26510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| FTM | Mesh, Surgical | 7 |
| DXZ | Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene | 4 |
| DXC | Clamp, Vascular | 3 |
| GXQ | Dura Substitute | 3 |
| DWP | Dilator, Vessel, Surgical | 2 |
| DTR | Heat-Exchanger, Cardiopulmonary Bypass | 1 |
| DWS | Instruments, Surgical, Cardiovascular | 1 |
| FTL | Mesh, Surgical, Polymeric | 1 |
| HQX | Implant, Orbital, Extra-Ocular | 1 |
| LLZ | System, Image Processing, Radiological | 1 |
| MTZ | Wrap, Implant, Orbital | 1 |
| PAJ | Mesh, Surgical, Non-Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 13, 2000 | K002233 | BVI SLING Bio-Vascular, Inc. | PAJ |
| Feb 22, 2000 | K992537 | PERI-STRIPS-SLEEVE, PERI-STRIPS-STRIP AND PERI-STRIPS DRY (NON-NAOH-TREATED AND NAOH-TREATED Bio-Vascular, Inc. | FTM |
| Nov 12, 1998 | K983602 | CV PERI-GUARD AND VASCU-GUARD Bio-Vascular, Inc. | DXZ |
| Nov 6, 1998 | K983581 | OCU-GUARD AND OCU-GUARD SUPPLE Bio-Vascular, Inc. | HQX |
| Oct 9, 1998 | K983162 | PERI-GUARD, CV PERI-GUARD, OCU-GUARD, SUPPLE PERI-GUARD, PERI-STRIPS - SLEEVE, PERI-STRIPS-STRIPS, PERI-STRIPS DRY, VASC Bio-Vascular, Inc. | FTM |
| Aug 4, 1998 | K981624 | FLO-THRU Bio-Vascular, Inc. | DXC |
| Jul 30, 1998 | K982282 | DURA-GUARD - DURAL REPAIR PATCH Bio-Vascular, Inc. | GXQ |
| Apr 10, 1998 | K971726 | CV PERI-GUARD - CARDIOVASCULAR PATCH Bio-Vascular, Inc. | DXZ |
| Dec 24, 1997 | K973706 | DURA-GUARD-DURAL REPAIR PATCH Bio-Vascular, Inc. | GXQ |
| Dec 16, 1997 | K973552 | OCU-GUARD ORBITAL IMPLANT WRAP, SUPPLE OCU-GUARD ORBITAL IMPLANT WRAP Bio-Vascular, Inc. | MTZ |
| May 9, 1997 | K971048 | PERI-STRIPS DRY - STAPLE LINE REINFORCEMENT Bio-Vascular, Inc. | FTM |
| Nov 27, 1996 | K963697 | ADVANCED DIAGNOSTIC VIEWER (ADV) Bio-Vascular, Inc. | LLZ |
| Jun 13, 1996 | K961811 | PERI-GUARD PERICARDIUM Bio-Vascular, Inc. | FTM |
| Jun 13, 1996 | K961810 | SUPPLE PERI-GUARD PERICARDIUM Bio-Vascular, Inc. | FTM |
| Jun 2, 1995 | K950956 | DURA-GUARD DURAL REPAIR PATCH, DURA-GUARD DURA SUBSTITUTE Bio-Vascular, Inc. | GXQ |
| Aug 1, 1994 | K942812 | FLO-RESTER DISPOSABLE VESSEL OCCLUDER Bio-Vascular, Inc. | DXC |
| Jul 8, 1994 | K942583 | PERI-STRIPS PLANAR CONFIGURATION STAPLE LINE REINFORCEMENT Bio-Vascular, Inc. | FTL |
| Jul 7, 1994 | K942010 | VASCU-GUARD Bio-Vascular, Inc. | DXZ |
| May 2, 1994 | K940205 | PERI-STRIPS Bio-Vascular, Inc. | FTM |
| Dec 21, 1992 | K923657 | SUPPLE PERI-GUARD Bio-Vascular, Inc. | FTM |
| Nov 4, 1992 | K921895 | TISSUE PATCH, TISSUE GRAFT Bio-Vascular, Inc. | DXZ |
| May 8, 1991 | K910682 | ROBICSEK PROBE/RETRACTOR Bio-Vascular, Inc. | DWP |
| Feb 7, 1991 | K905159 | FLO-RESTER(R) VESSEL SIZER Bio-Vascular, Inc. | DWP |
| Jan 19, 1990 | K896307 | INSULATION PAD Bio-Vascular, Inc. | DWS |
| Nov 30, 1988 | K883696 | FLO-RESTER Bio-Vascular, Inc. | DXC |
| Apr 29, 1986 | K860523 | CARDIO-COOL Bio-Vascular, Inc. | DTR |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||