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510(k) K101015

GUIDE CATHETERS AND ACCESSORIES by Thomas Medical Products, Inc. — Product Code DQY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 23, 2010
Date Received
April 12, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Percutaneous
Device Class
Class II
Regulation Number
870.1250
Review Panel
CV
Submission Type

Other clearances by Thomas Medical Products, Inc.

  • K122431 — HEARTSPAN STEERABLE INTRODUCER KIT (January 29, 2013)
  • K120158 — CORONARY SINUS GUIDE AND LATERAL VEIN INTRODUCER KITS (August 14, 2012)
  • 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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