Flo-Thru
FDA 510(k) K981624 · Bio-Vascular, Inc.
510(k) numberK981624
Submission
- Device name
- Flo-Thru
- Applicant
- Bio-Vascular, Inc.
St. Paul, MN, US - Received
- May 7, 1998
- Decision date
- August 4, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DXC – Clamp, Vascular
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4450
- Specialty
- Cardiovascular
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| K221661 | Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S)DXC · Traditional | Compression Works, Inc. | 03/03/2023SE |
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More from Vascular Graft Solutions, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
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| 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 |
| 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 |
Questions and answers
When was Flo-Thru cleared by the FDA?
Flo-Thru (K981624) received a 510(k) decision of Substantially Equivalent on August 4, 1998, 89 days after the submission was received.
What is the product code of K981624?
The FDA product code is DXC – Clamp, Vascular, a Class II (moderate risk) device regulated under 21 CFR 870.4450.