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510(k) K961780

HEMODIALYSIS INTRODUCER SET by Thomas Medical Products, Inc. — Product Code DYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 24, 1996
Date Received
May 8, 1996
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

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  • 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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