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510(k) K132943

INTRACARDIC CATHETER INTRODUCER KIT AND TRANSSEPTAL NEEDLE by Synaptic Medical Limited — Product Code DRC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 29, 2014
Date Received
September 19, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Trocar
Device Class
Class II
Regulation Number
870.1390
Review Panel
CV
Submission Type

Other clearances by Synaptic Medical Limited

  • K151936 — Steerable Intracardiac Catheter Introducer Kit and Transseptal Needle (December 4, 2015)
  • K133028 — RITHM ID ELECTROPHYSIOLOGY CATHETER (March 4, 2014)

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  • K130843 — SAFESEPT NEEDLE FREE TRANSSEPTAL TROCAR GUIDEWIRE (January 8, 2014)