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510(k) K140085

UNIVERSA PERCULTANEOUS DRAINAGE CATHETER by Cook Incorporated — Product Code FEW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 18, 2014
Date Received
January 13, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Malecot
Device Class
Class II
Regulation Number
876.5090
Review Panel
GU
Submission Type

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Other clearances for product code FEW

  • K070879 — BARD MALECOT AND PEZZER DRAINS (April 24, 2007)
  • K981258 — MANAN MALECOT BASKET DRAINAGE CATHETER (April 22, 1998)
  • K954147 — MANAN MALECOT BASKET DRAINAGE CATHETER (March 26, 1996)
  • K954116 — SILICONE MALECOT CATHETER WITH PEZZER/MUSHROOM TIP (November 6, 1995)
  • K920423 — OLYMPIC SMART SCALE CARE CENTER (June 11, 1992)