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

MICRINS MICRO ANASTOMOSIS CLAMP

K Number: K982278 · Decision Mar 26, 1999
Classifications
1
FEI Numbers
186
Registration Numbers
186
Same Product Code
203
Applicant Total
6
Review Days
270

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Basic Information

Device Name
MICRINS MICRO ANASTOMOSIS CLAMP
K Number
K982278
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
870.4450
Medical Specialty
Cardiovascular
Decision
Substantially Equivalent
Statement or Summary
Statement
Applicant
Micrins Surgical, Inc.
Date Received
June 29, 1998
Decision Date
March 26, 1999
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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Other Clearances by Micrins Surgical, Inc.

K Number Device Name
K993970 MICRINS MICROSURGICAL SUTURE
K933310 MICRINS CONTRAST BACKGROUND MATERIAL
K872989 MICRINS NEEDLE HOLDER
K872990 MICRINS SURGICAL SCISSOR
K872991 MICRINS FORCEPS 2010