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510(k) K001367

FAST-CATH 18F HEMOSTASIS INTRODUCER, MODEL 406XXX by St. Jude Medical, Inc. — Product Code DYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 31, 2000
Date Received
May 1, 2000
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

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  • 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)

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