The following data is part of a premarket notification filed by Vascular Solutions, Inc. with the FDA for Vascular Solutions Duett Flowable Hemostat.
| Device ID | K012293 |
| 510k Number | K012293 |
| Device Name: | VASCULAR SOLUTIONS DUETT FLOWABLE HEMOSTAT |
| Classification | Dressing, Wound, Drug |
| Applicant | VASCULAR SOLUTIONS, INC. 2495 XENIUM LN. NORTH Minneapolis, MN 55441 |
| Contact | Deborah L Jensen |
| Correspondent | Deborah L Jensen VASCULAR SOLUTIONS, INC. 2495 XENIUM LN. NORTH Minneapolis, MN 55441 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-20 |
| Decision Date | 2002-01-18 |
| Summary: | summary |