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510(k) K872724

SHEATH/DILATORS by Med-West, Inc. — Product Code DRE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 15, 1987
Date Received
July 8, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dilator, Vessel, For Percutaneous Catheterization
Device Class
Class II
Regulation Number
870.1310
Review Panel
CV
Submission Type

Other clearances by Med-West, Inc.

  • K880877 — CONTRAST INJECTION DEVICE (May 31, 1988)
  • K880398 — POWER TOILET ELEVATOR (March 17, 1988)
  • K874470 — MWI 400 WOUND DRESSING (December 18, 1987)
  • K854612 — ACUTE HEMODIALYSIS TRAY, CAT.#09-9540-7 (January 3, 1986)
  • K852162 — MNI 400 INJECTION CAPS (June 12, 1985)
  • K842342 — MWI 888 & 666 DOUBLE LUMEN SUBCLAVIAN (June 14, 1984)
  • K832124 — CPC, COUBLE LUMEN CARDIOPLEGIA-AIR ASPI (August 12, 1983)
  • K831828 — TEFLON FEMORAL CATHETER MWI 100,10 & (July 7, 1983)
  • K831440 — SINGLE NEEDLE SUBCLAVIAN VEIN MWI250/260 (June 3, 1983)
  • K831401 — SINGLE NEEDLE SUBCLAVIAN VEIN ACCESS (June 3, 1983)

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  • K241720 — VersaCross Connect™ Transseptal Dilator (July 12, 2024)
  • K233647 — VersaCross Connect™ Transseptal Dilator (December 14, 2023)
  • K232609 — Micro Ace™ Advanced Micro Access System (September 27, 2023)
  • K223472 — TightRail Guardian Motorized Dilator Sheath, 9 French (575-009); TightRail Guard (December 15, 2022)
  • K212784 — TightRail Guardian Motorized Dilator Sheath (August 24, 2022)
  • K211679 — Xtractor device (February 17, 2022)
  • K210734 — Endovascular Dilator and Sets (April 6, 2021)