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510(k) K924456

LONG LENGTH PERCUTANEOUS INTRODUCER SET by Thomas Medical Products, Inc. — Product Code DYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 22, 1993
Date Received
September 2, 1992
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.

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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)
  • 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)

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