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510(k) K093657

ADAGIO RETRACTING ECG LEAD WIRES by Acist Medical Systems, Inc. — Product Code DSA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 15, 2010
Date Received
November 25, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cable, Transducer And Electrode, Patient, (Including Connector)
Device Class
Class II
Regulation Number
870.2900
Review Panel
CV
Submission Type

Other clearances by Acist Medical Systems, Inc.

  • K233904 — ACIST RXi System (016616); ACIST Navvus II Catheter (016675_ (July 17, 2024)
  • K203004 — ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery System (December 17, 2020)
  • K193183 — ACIST HDi System, ACIST Kodama Intravascular Ultrasound Catheter (March 20, 2020)
  • K190473 — ACIST RXi System and Navvus II Catheter (September 13, 2019)
  • K191060 — ACIST CVI1 Contrast Delivery System, A1000 Syringe Kit, A1000V Syringe Kit, BT20 (July 18, 2019)
  • K191175 — ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System (June 27, 2019)
  • K171646 — ACISTCVi® Contrast Delivery System (February 16, 2018)
  • K173063 — ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System (October 23, 2017)
  • K172216 — ACIST RXi Mini System (August 18, 2017)
  • K132474 — CARDIOVASCULAR PRESSURE MEASUREMENT (CPM) SYSTEM, NAVVUS CATHETER (January 30, 2014)

Other clearances for product code DSA

  • K254114 — Baylis Connector Cable (January 18, 2026)
  • K252827 — IBP cable Becton Dickinson (2606488); IBP cable Edwards (2606489); IBP cable Abb (December 1, 2025)
  • K251669 — IBP transducer adapter cable, Argon/BD/Ohmeda, 2m; IBP transducer adapter cable, (September 30, 2025)
  • K242986 — SpO2 Extension Cable (May 2, 2025)
  • K243545 — Philips Reusable ECG Lead Sets and Trunk Cables : Model Number,Model Name: 98980 (January 17, 2025)
  • K240087 — RT Carbon ECG Leads (September 13, 2024)
  • K240377 — LIFEPAK® ECG Cables (May 7, 2024)
  • K240156 — LIFEPAK® Invasive Pressure Adapter Cable (Interfaces with ICU Medical Transpack (April 30, 2024)
  • K222712 — Fogg System Patient Monitoring Cables (November 22, 2023)
  • K230571 — RFP-100A Connector Cable (Single Use) (May 30, 2023)