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510(k) K860432

PERCUTANEOUS INTRODUCER KIT by Cormed, Inc., Sub. C.R.Bard, Inc. — Product Code DYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 1986
Date Received
February 4, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Introducer, Catheter
Device Class
Class II
Regulation Number
870.1340
Review Panel
CV
Submission Type

Other clearances by Cormed, Inc., Sub. C.R.Bard, Inc.

  • K863606 — BUTTERFLY NON-CORING NEEDLE SET (December 18, 1986)
  • K854019 — PORT-GARD (November 26, 1985)
  • K850967 — STERILE CORMED MEDIPORT (May 17, 1985)
  • K850674 — CORMED II AMBULATORY INFUSION PUMP (April 9, 1985)
  • K843083 — CORMED HUBER POINT NEEDLE (September 5, 1984)
  • K833915 — VASCULAR ACCESS CATH. REPAIR KIT (March 30, 1984)
  • K823553 — CORCATH H & B VASCULAR ACCESS CATHETER (January 5, 1983)

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