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510(k) K182660

GaltTWS by Galt Medical Corp. — Product Code DRB

K182660 is an FDA 510(k) premarket notification submitted by Galt Medical Corp. for the device "GaltTWS". The FDA issued a decision of Substantially Equivalent on May 30, 2019. The device falls under product code DRB (Stylet, Catheter), a Class II device regulated under 21 CFR 870.1380. Galt Medical Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 30, 2019
Date Received
September 25, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stylet, Catheter
Device Class
Class II
Regulation Number
870.1380
Review Panel
CV
Submission Type

Other clearances by Galt Medical Corp.

  • K192195 — Sterile Dilator (September 26, 2019)
  • K173287 — Elite HV Radial (December 21, 2017)
  • K172487 — Coaxial Dilator Set (Micro-Introducer) (October 16, 2017)
  • K153533 — Tearaway Introducer Sheath, MicroSlide Tearaway Introducer (July 5, 2016)
  • K152528 — Attachable Cath Lab Hemostasis Valve (December 2, 2015)
  • K140028 — GALT VTI LOW INSERTION VALVE TEARAWAY INTRODUCER (August 21, 2014)
  • K123430 — MICROSLIDER TEARAWAY INTRODUCER SET (April 12, 2013)
  • K112398 — TRIV(TM) VALVED TEARAWAY INTRODUCER, TIRV(TM) VALVED TEARAWAY INTRODUCER WITH SI (April 12, 2012)
  • K071330 — GALTSTICK INTRODUCER SYSTEM (October 31, 2007)
  • K043525 — CATHETER INTRODUCER (February 9, 2005)

Other clearances for product code DRB

  • K220280 — Arrow Stiffening Stylet (August 30, 2022)
  • K191469 — Biotronik Stylets (August 1, 2019)
  • K170298 — Liberator Beacon Tip Locking Stylet (October 18, 2017)
  • K142116 — LLD EZ (August 12, 2014)
  • K090163 — STYLET, MODELS 4060, 4062, 4064, 4090, 4091 AND 4078 (April 1, 2009)
  • K080924 — MOND RVOT STYLET MODELS 4140, 4141, 4150, 4151 (April 30, 2008)
  • K072864 — ST. JUDE MEDICAL, CPS DUO LEFT HEART LEAD DELIVERY SYSTEM (March 13, 2008)
  • K053019 — ACUITY STEERABLE STYLET ACCESSORY (March 3, 2006)
  • K052965 — EASYTRAK 2 STYLET, MODELS 4826, 4829, 4832. (February 13, 2006)
  • K043401 — SPECTRANETICS LLD CS, MODEL 518-039 (March 16, 2005)

FDA data resources