The following data is part of a premarket notification filed by Forge Medical, Inc. with the FDA for Vasostat Hemostasis Device.
| Device ID | K153259 |
| 510k Number | K153259 |
| Device Name: | VasoStat Hemostasis Device |
| Classification | Clamp, Vascular |
| Applicant | FORGE MEDICAL, INC. 701 W BROAD ST, SUITE 102 Bethlehem, PA 18018 |
| Contact | Timothy Clark |
| Correspondent | Mason Diamond TEXEL FORTIS, LLC 150 LEVINBERG LANE Wayne, NJ 07470 |
| Product Code | DXC |
| CFR Regulation Number | 870.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-11-10 |
| Decision Date | 2016-01-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00863879000201 | K153259 | 000 |