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510(k) K961513

PROCATH LOCKING PEEL-AWAY INTRODUCER/PEEL-AWAY INTRODUCER SET by Ep Medsystems — Product Code DYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 13, 1996
Date Received
April 19, 1996
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 Ep Medsystems

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  • K071028 — VIEWMATE SYSTEM (May 1, 2007)
  • K070706 — EP-WORKMATE (April 11, 2007)
  • K063277 — MAPMATE (November 30, 2006)
  • K063113 — EP-WORKMATE (October 27, 2006)
  • K041442 — EP-4 CLINICAL STIMUTATOR (September 14, 2004)
  • K033963 — EP DEFLECTABLE CATHETERS (April 15, 2004)
  • K040207 — EP-4 CLINICAL STIMULATOR (February 27, 2004)
  • K031066 — VIEWMATE ULTRASOUND IMAGING SYSTEM (October 17, 2003)

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