Home / 510(k) Clearances / K810859

510(k) K810859

SINGLE USE SELDINGER/COURNAND PERC. NDL by Procedure Products, Inc. — Product Code DRE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 11, 1981
Date Received
March 30, 1981
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 Procedure Products, Inc.

  • K161812 — Freedom Syringe (March 27, 2017)
  • K923194 — INSUFFLATOR CONNECTING FILTER (October 8, 1993)
  • K922536 — TORQUE DEVICE (December 10, 1992)
  • K914128 — CONNECTING SET (November 27, 1991)
  • K910673 — BAG SPIGOT (April 24, 1991)
  • K884985 — MODIFIED 10CC SYRINGE CONTROL RING SET (December 20, 1988)
  • K874747 — 10CC SYRINGE CONTROL RING SET (February 4, 1988)
  • K874037 — ANGIO WASTE FLUIDS DUMP BAG (January 29, 1988)
  • K853749 — CUSTOM CORONARY MANIFOLD KITS (January 13, 1986)
  • K842173 — DISPOSABLE STOPCOCKS (September 5, 1984)

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)