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510(k) K123475

SHOOCIN INTRODUCER KIT by Lepu Medical Technology (Beijing) Co., Ltd. — Product Code DYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 3, 2014
Date Received
November 13, 2012
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 Lepu Medical Technology (Beijing) Co., Ltd.

  • K172331 — Type I, Type II, Type III, Type IV (March 2, 2018)
  • K172099 — Shoocin Introducer Kit (October 5, 2017)
  • K141707 — ULTRASKIN HYDROPHILIC GUIDE WIRE (January 21, 2015)
  • K142359 — Vasc Band hemostat (October 23, 2014)
  • K123473 — HOPER PTCA BALLOON CATHETER (August 13, 2013)
  • K111837 — RADIAL ARTERY COMPRESSION TOURNIQUET (September 27, 2011)

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