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510(k) K951313

MEDAMICUS PERCUTANEOUS INTRODUCER by Medamicus, Inc. — Product Code DYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 27, 1995
Date Received
March 23, 1995
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 Medamicus, Inc.

  • K040150 — MODIFICATION TO MEDAMICUS FLOWGUARD PEELABLE INTRODUCER (February 18, 2004)
  • K030905 — MEDAMICUS FLOWGUARD PEELABLE INTRODUCER (April 9, 2003)
  • K022689 — MODIFICATION TO MEDAMICUS AXIA RSN (August 23, 2002)
  • K021004 — VALVED PEELABLE INTRODUCER (June 6, 2002)
  • K020563 — MEDAMICUS AXIA RSN (May 21, 2002)
  • K013120 — PERCUTANEOUS INTRODUCER SET, MODEL 042294 AND KIT MODEL 3550-18 (January 24, 2002)
  • K011085 — GUIDEWIRE INTRODUCER SAFETY NEEDLE (July 9, 2001)
  • K000824 — PERCUTANEOUS INTRODUCER, MODEL 10383-XXX (April 13, 2000)
  • K994097 — MEDAMICUS EPIDURAL INTRODUCER (March 1, 2000)
  • K990705 — MEDAMICUS COAXIAL INTRODUCER KIT, 10330-XXX, BOSTON SCIENTIFIC COAXIAL DILATOR S (June 28, 1999)

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