Flo-Rester
FDA 510(k) K883696 · Bio-Vascular, Inc.
510(k) numberK883696
Submission
- Device name
- Flo-Rester
- Applicant
- Bio-Vascular, Inc.
St. Paul, MN, US - Received
- August 30, 1988
- Decision date
- November 30, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DXC – Clamp, Vascular
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4450
- Specialty
- Cardiovascular
Other 510(k)s with product code DXC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262086 | PreludeSYNC Radial Compression DeviceDXC · Special | Merit Medical Systems, Inc. | 07/22/2026SE |
| K260105 | Fogarty Spring Clips, Handleless Clamps, and Clamp InsertsDXC · Traditional | Edwards Lifesciences | 06/05/2026SE |
| K252772 | Arc Adjustable Radial Cuff Compression DeviceDXC · Traditional | Tz Medical, Inc. | 05/22/2026SE |
| K254060 | Life Saving TourniquetDXC · Traditional | TW Medical | 04/03/2026SE |
| K243627 | Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction Clamp…DXC · Traditional | Arc Trauma, LLC | 12/31/2025SE |
| K253070 | Namic Radial Arm Band, 23 cm (DYNJRADBAND); Namic Radial Arm Band, 26 cm (DYNJRADBANDL)DXC · Traditional | Medline Industries, LP | 11/20/2025SE |
| K232577 | Radial Compression DeviceDXC · Traditional | Ningbo Dizegens Medical Science Co.,Ltd | 01/18/2024SE |
| K230281 | PicoclampDXC · Traditional | Kono Seisakusho Co., Ltd. | 10/23/2023SE |
| K221661 | Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S)DXC · Traditional | Compression Works, Inc. | 03/03/2023SE |
| K230248 | ViolaDXC · Special | Vascular Graft Solutions, Ltd. | 02/28/2023SE |
More from Vascular Graft Solutions, Ltd.
| 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 |
Questions and answers
When was Flo-Rester cleared by the FDA?
Flo-Rester (K883696) received a 510(k) decision of Substantially Equivalent on November 30, 1988, 92 days after the submission was received.
What is the product code of K883696?
The FDA product code is DXC – Clamp, Vascular, a Class II (moderate risk) device regulated under 21 CFR 870.4450.