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510(k) K993024

CELSITE IMPLANTABLE PORT WITH VALVED CATHETER by B. Braun of America, Inc. — Product Code LJT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 13, 2000
Date Received
September 9, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Port & Catheter, Implanted, Subcutaneous, Intravascular
Device Class
Class II
Regulation Number
880.5965
Review Panel
HO
Submission Type

Other clearances by B. Braun of America, Inc.

  • K983794 — CHEMO MINI SPIKE PLUS (March 23, 1999)
  • K946170 — COMFORT-Q SUBCUTANEOUS INJECTION SETS (November 3, 1995)
  • K945850 — BRAUN DIACAN(R) FISTULA NEEDLES (October 6, 1995)
  • 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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