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510(k) K160716

The Nanostim Introducer Kit by St. Jude Medical, Inc. — Product Code DYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 14, 2016
Date Received
March 15, 2016
Clearance Type
Special
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 St. Jude Medical, Inc.

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  • K163407 — Confirm Rx Insertable Cardiac Monitor (ICM) System (September 29, 2017)
  • K161171 — PressureWire X Guidewire (August 15, 2016)
  • K161102 — Nanostim Introducer Kit (May 19, 2016)
  • K140793 — NANOSTIM INTRODUCER KIT (December 17, 2014)
  • K133481 — SJM CONFIRM IMPLANTABLE CARDIAC MONITOR (ICM) (May 28, 2014)
  • K131592 — ENLIGHTN RENAL GUIDE CATHETER (January 31, 2014)
  • K073700 — 6F PROXIS SYSTEM (October 2, 2008)
  • K042734 — SJM RIGID SADDLE RING MODEL RSAR-(SIZE) (December 17, 2004)
  • K022363 — SJM TAILOR ANNULOPLASTY BAND, MODEL TAB-(SIZE) (TAILOR BAND) (September 19, 2002)

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