FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

V. Mueller Cosgrove Flex Clamps, Model Number-CV1033, CV1061, CV1133, CV1161, CV1186

K Number: K210324 · Decision Mar 4, 2021
Classifications
1
FEI Numbers
186
Registration Numbers
186
Same Product Code
203
Applicant Total
12
Review Days
28

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Basic Information

Device Name
V. Mueller Cosgrove Flex Clamps, Model Number-CV1033, CV1061, CV1133, CV1161, CV1186
K Number
K210324
Device Class
FDA class 2
Clearance Type
Special
Regulation Number
870.4450
Medical Specialty
Cardiovascular
Decision
Substantially Equivalent
Statement or Summary
Summary
Applicant
Carefusion 2200, Inc.
Date Received
February 4, 2021
Decision Date
March 4, 2021
Product Code
DXC
Advisory Committee
Cardiovascular
Review Advisory Committee
CV
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
DXC Clamp, Vascular

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