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510(k) K163358

Introcan Safety 3 Closed IV Catheter by B.Braun Melsungen AG — Product Code FOZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 28, 2017
Date Received
November 30, 2016
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Device Class
Class II
Regulation Number
880.5200
Review Panel
HO
Submission Type

Other clearances by B.Braun Melsungen AG

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  • K131040 — EXTAVIPRO STERICAN 30G (July 15, 2013)
  • K111236 — INTROCAN SAFETY (R) 3 CLOSED IV CATHETER 18GA X 1-3/4 (45MM) AND 18GA X 1-1/4 (3 (August 30, 2011)
  • K102033 — COMBITRANS MONITORING SETS AND ACCESSORIES (April 7, 2011)

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