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510(k) K012562

MEDCOMP 14.5F DOUBLE LUMEN HEMODIALYSIS CATHETER by Medical Components, Inc. — Product Code MSD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 8, 2002
Date Received
August 8, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Hemodialysis, Implanted
Device Class
Class II
Regulation Number
876.5540
Review Panel
GU
Submission Type

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  • K122423 — VASU-PICC (December 12, 2012)
  • K121848 — SPLIT CATH III 24CM SPLIT CATH III 24CM SPLIT CATH III 32CM CATH III 36CM SPLIT (September 21, 2012)

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