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510(k) K072745

Y-GLIDE by Thomas Medical Products, Inc. — Product Code DTL

K072745 is an FDA 510(k) premarket notification submitted by Thomas Medical Products, Inc. for the device "Y-GLIDE". The FDA issued a decision of Substantially Equivalent on January 4, 2008. The device falls under product code DTL (Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4290. Thomas Medical Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 4, 2008
Date Received
September 27, 2007
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4290
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)
  • K101015 — GUIDE CATHETERS AND ACCESSORIES (September 23, 2010)
  • K083269 — CROSSOVER (February 3, 2009)
  • K081341 — REINFORCED CATHETER INTRODUCER SYSTEM (RCIS) (May 14, 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)

Other clearances for product code DTL

  • K152528 — Attachable Cath Lab Hemostasis Valve (December 2, 2015)
  • K143429 — Passage Hemostasis Valve (December 22, 2014)
  • K140475 — ROTATING ADAPTERS (April 16, 2014)
  • K131124 — COLIGN (August 28, 2013)
  • K123448 — AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH BALANCE BIOSURFACE, AFFINITY FLEXIBLE L (December 13, 2012)
  • K122811 — CONNECTOR COMPONENTS WITH BALANCE BIOSURFACE (October 12, 2012)
  • K122301 — GUARDIAN II HEMOSTASIS VALVE GUARDIAN II NC HEMOSTASIS VALVE (September 7, 2012)
  • K120069 — MEDLINE STOPCOCK AND MANIFOLD (April 3, 2012)
  • K113148 — E-PASS (February 28, 2012)
  • K113845 — TUBING, CONMNECTORS, AND ACCESSORIES WIT BALANCE BIOSURFACE (January 25, 2012)

FDA data resources