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510(k) K111644

MOBICATH TRANSSEPTAL NEEDLE by Great Batch Medical — Product Code DRC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 3, 2011
Date Received
June 13, 2011
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

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  • K172950 — TSN Transseptal Needle (February 21, 2018)
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  • K172893 — SafeSept Needle Free Transseptal Guidewire (December 21, 2017)
  • K170671 — SafeSept Transseptal Guidewire (October 20, 2017)
  • K132943 — INTRACARDIC CATHETER INTRODUCER KIT AND TRANSSEPTAL NEEDLE (August 29, 2014)