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510(k) K022238

MYOCARDIAL LEAD IMPLANT TOOL, MODEL 10626 by Medtronic Vascular — Product Code DWS

K022238 is an FDA 510(k) premarket notification submitted by Medtronic Vascular for the device "MYOCARDIAL LEAD IMPLANT TOOL, MODEL 10626". The FDA issued a decision of Substantially Equivalent on October 9, 2002. The device falls under product code DWS (Instruments, Surgical, Cardiovascular), a Class I device regulated under 21 CFR 870.4500. Medtronic Vascular has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 9, 2002
Date Received
July 11, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instruments, Surgical, Cardiovascular
Device Class
Class I
Regulation Number
870.4500
Review Panel
CV
Submission Type

Other clearances by Medtronic Vascular

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  • K232190 — 6F Sherpa NX Balanced Guide Catheter, 7F Sherpa NX Balanced Guide Catheter (August 22, 2023)
  • K230156 — 5F Launcher Guide Catheter, 6F Launcher Guide Catheter, 7F Launcher Guide Cathet (June 30, 2023)
  • K220773 — Everest 20 Inflation Device and 3-way Stopcock (AC2200);Everest 30 Inflation Dev (April 13, 2022)
  • K192296 — Medtronic 6F Taiga Guiding Catheter (September 20, 2019)
  • K182957 — Heli-FX EndoAnchor System (November 21, 2018)
  • K173515 — Admiral Xtreme (April 12, 2018)
  • K171866 — Sentrant Introducer Sheath with Hydrophilic Coating (December 20, 2017)
  • K170191 — SilverHawk Peripheral Plaque Excision System, TurboHawk Peripheral Plaque Excisi (June 16, 2017)
  • K171427 — Heli-FX Applier, Heli-FX Guide, Ancillary EndoAnchor Cassette (June 13, 2017)

Other clearances for product code DWS

  • K964445 — OCTOPUS TISSUE STABILIZER (28001/28002/28003/28004/28005/28006) (January 30, 1997)
  • K962771 — BURKE CONGENITAL THORACOSCOPY INSTRUMENTS (November 19, 1996)
  • K955689 — RNS STERILE, DISPOSABLE DIGITAL ANGIOGRAPHIC TRAY (May 15, 1996)
  • K960139 — G.E. STERILE ANGIOGRAPHIC TRAY (April 19, 1996)
  • K960144 — G.E. STERILE CT BIOPSY TRAY (April 15, 1996)
  • K960143 — G.E. STERILE DIGITAL ANGIOGRAPHIC TRAY (April 9, 1996)
  • K934727 — REPLACEMENT PARTS FOR CPI 6888 LEAD TUNNELER (January 10, 1994)
  • K900379 — HYCULT DIAMOND CORONARY BYPASS KNIFE (March 19, 1990)
  • K896307 — INSULATION PAD (January 19, 1990)
  • K894738 — MODEL 6888 LEAD TUNNELER (September 13, 1989)

FDA data resources