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510(k) K021004

VALVED PEELABLE INTRODUCER by Medamicus, Inc. — Product Code DYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 6, 2002
Date Received
March 28, 2002
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.

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  • K022689 — MODIFICATION TO MEDAMICUS AXIA RSN (August 23, 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)
  • K965167 — PERCUTANEOUS VENOUS INTRODUCER 10264 (July 25, 1997)

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