510(k) K210324

V. Mueller Cosgrove Flex Clamps, Model Number-CV1033, CV1061, CV1133, CV1161, CV1186 by Carefusion 2200, Inc. — Product Code DXC

K210324 is an FDA 510(k) premarket notification submitted by Carefusion 2200, Inc. for the device "V. Mueller Cosgrove Flex Clamps, Model Number-CV1033, CV1061, CV1133, CV1161, CV1186". The FDA issued a decision of Substantially Equivalent on March 4, 2021. The device falls under product code DXC (Clamp, Vascular), a Class II device regulated under 21 CFR 870.4450. Carefusion 2200, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 4, 2021
Date Received
February 4, 2021
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Clamp, Vascular
Device Class
Class II
Regulation Number
870.4450
Review Panel
CV
Submission Type