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510(k) K130855

PTFE SUPER SHEATH INTRODUCER by Martech Medical Products — Product Code DYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 29, 2013
Date Received
March 28, 2013
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 Martech Medical Products

  • K120617 — PTFE SUPER SHEATH INTRODUCER (November 19, 2012)
  • K101399 — COAXIAL INTRODUCER SET (June 17, 2010)
  • K960519 — MARTECH ENDOSCOPIC INJECTION NEEDLE (May 1, 1996)
  • K931924 — MARKSMAN ARTERIAL BLOOD GAS SYRINGE (August 3, 1993)
  • K922438 — PRO2 OXYGEN ANALYZER (March 5, 1993)
  • K926007 — ACCESSORY TO PISTON SYRINGE (February 23, 1993)
  • K914778 — NEOLINE(TM) (September 16, 1992)
  • K910970 — MARKSMAN ARTERIAL BLOOD GAS SYRINGE (October 15, 1991)
  • K890473 — NEEDLE GUARD(TM) (April 3, 1989)

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