Bio-Vascular, Inc.
Medical device manufacturer in St. Paul, MN.
26510(k) clearances
0PMA approvals
0recalls
Device types
- FTM Mesh, Surgical 7
- DXZ Patch, Pledget And Intracardiac, Petp… 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
- LLZ System, Image Processing, Radiological 1
- MTZ Wrap, Implant, Orbital 1
- HQX Implant, Orbital, Extra-Ocular 1
- PAJ Mesh, Surgical, Non-Synthetic… 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K002233 | Bvi SlingPAJ · Traditional | 10/13/2000SE |
| K992537 | Peri-Strips-Sleeve, Peri-Strips-Strip and Peri-Strips Dry (Non-Naoh-Treated and…FTM · Traditional | 02/22/2000SE |
| K983602 | CV Peri-Guard and Vascu-GuardDXZ · Special | 11/12/1998SE |
| K983581 | Ocu-Guard and Ocu-Guard SuppleHQX · Special | 11/06/1998SE |
| K983162 | Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips - Sleeve…FTM · Special | 10/09/1998SE |
| K981624 | Flo-ThruDXC · Traditional | 08/04/1998SE |
| K982282 | Dura-Guard - Dural Repair PatchGXQ · Special | 07/30/1998SE |
| K971726 | CV Peri-Guard - Cardiovascular PatchDXZ · Traditional | 04/10/1998SE |
| K973706 | Dura-Guard-Dural Repair PatchGXQ · Traditional | 12/24/1997SE |
| K973552 | Ocu-Guard Orbital Implant Wrap, Supple Ocu-Guard Orbital Implant WrapMTZ · Traditional | 12/16/1997SE |
| K971048 | Peri-Strips Dry - Staple Line ReinforcementFTM · Traditional | 05/09/1997SE |
| K963697 | Advanced Diagnostic Viewer (Adv)LLZ · Traditional | 11/27/1996SE |
| K961811 | Peri-Guard PericardiumFTM · Traditional | 06/13/1996SE |
| K961810 | Supple Peri-Guard PericardiumFTM · Traditional | 06/13/1996SE |
| K950956 | Dura-Guard Dural Repair Patch, Dura-Guard Dura SubstituteGXQ · Traditional | 06/02/1995SE |
| K942812 | Flo-Rester Disposable Vessel OccluderDXC · Traditional | 08/01/1994SE |
| K942583 | Peri-Strips Planar Configuration Staple Line ReinforcementFTL · Traditional | 07/08/1994SE |
| K942010 | Vascu-GuardDXZ · Traditional | 07/07/1994SE |
| K940205 | Peri-StripsFTM · Traditional | 05/02/1994SE |
| K923657 | Supple Peri-GuardFTM · Traditional | 12/21/1992SE |
| K921895 | Tissue Patch, Tissue GraftDXZ · Traditional | 11/04/1992SESP |
| K910682 | Robicsek Probe/RetractorDWP · Traditional | 05/08/1991SE |
| K905159 | Flo-Rester(R) Vessel SizerDWP · Traditional | 02/07/1991SE |
| K896307 | Insulation PadDWS · Traditional | 01/19/1990SE |
| K883696 | Flo-ResterDXC · Traditional | 11/30/1988SE |
| K860523 | Cardio-CoolDTR · Traditional | 04/29/1986SE |