Home / 510(k) Clearances / K913027

510(k) K913027

VESSEL DILATOR by Deseret Medical, Inc. — Product Code DRE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 27, 1991
Date Received
July 9, 1991
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 Deseret Medical, Inc.

  • K904648 — SAFE SYTE I.V. CATHETER PLACEMENT UNIT (December 14, 1990)
  • K904121 — VIALON OBTURATOR (November 8, 1990)
  • K904122 — INSYTE-A ARTERIAL CATHETERIZATION UNIT (October 4, 1990)
  • K900116 — DESERET OPTIMA INTRAVASCULAR CATHETER (June 18, 1990)
  • K895735 — DESERET MULTILUMEN SUBCLAVIAN CATHETER (May 18, 1990)
  • K895734 — DESERET INTRAVASCULAR CATHETER (April 9, 1990)
  • K894033 — DISPOSABLE CATHETER PRESSURE TRANSDUCER (October 17, 1989)
  • K893406 — DESERET PRN ADAPTER (June 22, 1989)
  • K882798 — MULTIFLO ADAPTER (July 18, 1988)
  • K882797 — LUER-LOK MULTIFLO ADAPTER (July 18, 1988)

Other clearances for product code DRE

  • K253616 — ProtekDilate Vascular Access Kit (December 19, 2025)
  • K251325 — VersaCross Connect™ Transseptal Dilator (May 29, 2025)
  • K242229 — Micro Ace Gold Advanced Micro Access System (January 15, 2025)
  • 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)