The following data is part of a premarket notification filed by Vasoinnovations Inc. with the FDA for Vasoband Vascular Compression Device.
| Device ID | K190318 |
| 510k Number | K190318 |
| Device Name: | VASOBand Vascular Compression Device |
| Classification | Clamp, Vascular |
| Applicant | VASOInnovations Inc. 1260 Huntington Drive, Suite 208 South Pasadena, CA 91030 |
| Contact | Raj Sardesai |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1394 25TH STREET, NW Buffalo, MN 55313 |
| Product Code | DXC |
| CFR Regulation Number | 870.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2019-02-13 |
| Decision Date | 2019-03-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860004749752 | K190318 | 000 |
| 00860004749745 | K190318 | 000 |
| 00860004749738 | K190318 | 000 |
| 00860004749721 | K190318 | 000 |
| 00866691000312 | K190318 | 000 |
| 00860004749714 | K190318 | 000 |