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

IV FLUID TRANSFER PIN

K Number: K925401 · Decision Mar 3, 1993
Classifications
1
FEI Numbers
177
Registration Numbers
177
Same Product Code
205
Applicant Total
19
Review Days
128

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Basic Information

Device Name
IV FLUID TRANSFER PIN
K Number
K925401
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
880.5440
Medical Specialty
General Hospital
Decision
Substantially Equivalent
Statement or Summary
Summary
Applicant
B. Braun of America, Inc.
Date Received
October 26, 1992
Decision Date
March 3, 1993
Product Code
LHI
Advisory Committee
General Hospital
Review Advisory Committee
HO
Third Party
N

Classifications

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

Product Code Device Name
LHI Set, I.V. Fluid Transfer

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K942988 FILTERED EXTENSION SETS
K945752 CELSITE(TM) BRACHIAL VENOUS PORT
K945551 CELSITE(TM) DUAL VENOUS SYSTEM
K943770 LOW VOLUME MULTIPORT
K950982 B. BRAUN SONOCAN BIOPSY NEEDLE AND ASPIRATION HANDLE
K950184 B. BRAUN IV START KITS
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