The following data is part of a premarket notification filed by Venturemed Group, Inc. with the FDA for Flex Vessel Prep System.
| Device ID | K202187 |
| 510k Number | K202187 |
| Device Name: | FLEX Vessel Prep System |
| Classification | Catheter, Percutaneous, Cutting/scoring |
| Applicant | VentureMed Group, Inc. 2800 Camput Drive, Suite 50 Plymouth, MN 55441 |
| Contact | Jill Schweiger |
| Correspondent | Jill Schweiger VentureMed Group, Inc. 2800 Camput Drive, Suite 50 Plymouth, MN 55441 |
| Product Code | PNO |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-08-04 |
| Decision Date | 2020-09-11 |