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510(k) K043438

LARGE BORE SPLITTABLE INTRODUCER KIT by Thomas Medical Products, Inc. — Product Code DYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 15, 2005
Date Received
December 14, 2004
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 Thomas Medical Products, Inc.

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  • 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)
  • 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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