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510(k) K122431

HEARTSPAN STEERABLE INTRODUCER KIT by Thomas Medical Products, Inc. — Product Code DYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 29, 2013
Date Received
August 10, 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 Thomas Medical Products, Inc.

  • K120158 — CORONARY SINUS GUIDE AND LATERAL VEIN INTRODUCER KITS (August 14, 2012)
  • K101015 — GUIDE CATHETERS AND ACCESSORIES (September 23, 2010)
  • K083269 — CROSSOVER (February 3, 2009)
  • K081341 — REINFORCED CATHETER INTRODUCER SYSTEM (RCIS) (May 14, 2008)
  • K072745 — Y-GLIDE (January 4, 2008)
  • K043438 — LARGE BORE SPLITTABLE INTRODUCER KIT (February 15, 2005)
  • K040713 — MODIFICATION TO BRAIDED GUIDING INTRODUCER SYSTEM (June 1, 2004)
  • K011727 — TRANSSEPTAL NEEDLE/TROCAR (May 2, 2002)
  • K020090 — MODIFICATION TO TRANSSEPTAL INTRODUCER SET (February 11, 2002)
  • K013202 — MODIFICATION TO BRAIDED GUIDING INTRODUCER (October 23, 2001)

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