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510(k) K910566

VERSACATH(TM) MULTILUMEN SYSTEM by Menlo Care, Inc. — Product Code FOZ

Clearance Details

Decision
SEKD (Substantially Equivalent (kit, denovo))
Decision Date
June 3, 1991
Date Received
February 8, 1991
Clearance Type
Traditional
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 Menlo Care, Inc.

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  • K945521 — CENTERMARK(R) PICC INSERTION TRAY LANDMARK(R) MIDLINE CATHETER PREP TRAY (April 6, 1995)
  • K950737 — LANDMARK MIDLINE CATHETER (March 29, 1995)
  • K944968 — LANDMARK MIDLINE CATHETER (March 29, 1995)
  • K943893 — PERCUTANEOUS GRAINAGE CATHETER (March 7, 1995)
  • K943143 — BILIARY STENT (February 28, 1995)
  • K930048 — SAFE-PICC CATHETER (May 12, 1994)
  • K933941 — MENLO CARE URINARY DIVERSION STENT (March 31, 1994)
  • K940127 — CENTERMARK SECURING WINGS (February 9, 1994)

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