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510(k) K945850

BRAUN DIACAN(R) FISTULA NEEDLES by B. Braun of America, Inc. — Product Code FIE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 6, 1995
Date Received
November 30, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Fistula
Device Class
Class II
Regulation Number
876.5540
Review Panel
GU
Submission Type

Other clearances by B. Braun of America, Inc.

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  • K942988 — FILTERED EXTENSION SETS (July 14, 1995)
  • K945752 — CELSITE(TM) BRACHIAL VENOUS PORT (May 31, 1995)
  • K945551 — CELSITE(TM) DUAL VENOUS SYSTEM (April 21, 1995)
  • K943770 — LOW VOLUME MULTIPORT (April 10, 1995)
  • K950982 — B. BRAUN SONOCAN BIOPSY NEEDLE AND ASPIRATION HANDLE (April 4, 1995)
  • K950184 — B. BRAUN IV START KITS (March 15, 1995)
  • K943181 — DISPENSING PIN WITH ONE-WAY VALVE (September 29, 1994)

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  • K112734 — APLAN A.V. FISTULA NEEDLE SET (April 24, 2012)
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