The following data is part of a premarket notification filed by Carefusion 2200 Inc with the FDA for V. Mueller Cosgrove Flex Clamps, Model Number-cv1033, Cv1061, Cv1133, Cv1161, Cv1186.
Device ID | K210324 |
510k Number | K210324 |
Device Name: | V. Mueller Cosgrove Flex Clamps, Model Number-CV1033, CV1061, CV1133, CV1161, CV1186 |
Classification | Clamp, Vascular |
Applicant | CareFusion 2200 Inc 75 North Fairway Drive Vernon Hills, IL 60061 |
Contact | Jane Weber |
Correspondent | Jane Weber CareFusion 2200 Inc 75 North Fairway Drive Vernon Hills, IL 60061 |
Product Code | DXC |
CFR Regulation Number | 870.4450 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-02-04 |
Decision Date | 2021-03-04 |