Home / 510(k) Clearances / K162181

510(k) K162181

Protek Duo Venous Dilator Set, Protek Solo Venous Dilator Set by Cardiacassist, Inc. — Product Code DRE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 6, 2017
Date Received
August 4, 2016
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 Cardiacassist, Inc.

  • K233736 — LifeSPARC System (January 19, 2024)
  • K232480 — ProtekDuo Veno-Venous Cannula Sets (October 6, 2023)
  • K232132 — LifeSPARC System (August 3, 2023)
  • K211830 — LifeSPARC System (November 15, 2022)
  • K202751 — TandemHeart Pump and Escort Controller (March 26, 2021)
  • K183623 — LifeSPARC Pump, LifeSPARC Controller (July 9, 2019)
  • K181150 — ProtekDuo Mini Veno-Venous Cannula Set (May 25, 2018)
  • K162214 — Protek Solo 24 Fr Venous Cannula Set (November 30, 2016)
  • K160257 — PROTEK Duo 31 Fr. Veno-Venous Cannula Set (March 4, 2016)
  • K153295 — TandemLung Oxygenator (February 26, 2016)

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)