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 |