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510(k) K190789

IntelliCartTM System by Dornoch Medical Systems — Product Code JCX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 24, 2019
Date Received
March 27, 2019
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Suction, Ward Use, Portable, Ac-Powered
Device Class
Class II
Regulation Number
878.4780
Review Panel
SU
Submission Type

Other clearances by Dornoch Medical Systems

  • K172481 — IntelliCart System (September 14, 2017)
  • K162421 — IntelliCartTM System (December 21, 2016)
  • K133786 — DORNOCH DUO SUCTION CART WITH: DL2800 LID, CL500 LID, DORNOCH QUAD SUCTION CART (March 21, 2014)
  • K123188 — DORNOCH DUO SUCTION CART WITH DL2800 LID MODEL UL-DU2800, DORNOCH DUO SUCTION CA (March 4, 2013)
  • K081047 — TRANSPOSAL ULTRA SYSTEMS (April 29, 2008)

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  • K243418 — Riptide™ Aspiration Pump; Riptide™ Collection Canister with Intermediate Tubing (December 2, 2024)
  • K233428 — Easycess Aspiration Pump (November 3, 2023)
  • K222552 — 120V Neptune S Rover (0711-001-000);V2 4-Port Manifold (0750-400-000);V2 Specime (December 9, 2022)
  • K182950 — Acare Suction Unit (August 23, 2019)
  • K190105 — ZOOM Aspiration Pump (February 21, 2019)
  • K180115 — TWBM Pump (July 24, 2018)
  • K181398 — DV-300 Aspirator (July 23, 2018)
  • K172481 — IntelliCart System (September 14, 2017)