Coordinator, Cable Input

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K914725 ↗

FDA Product Code

DPS

Device Class

Class II

Regulation

21 CFR Part 870.2340

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Traid-Ep, Plate Input, W/Pulse Blanking Circuitry

  Class II

  FDA 510(k) K883304 Active Cleared 9 Nov 1988

• Triad-Ep II, Pushbutton, Cable Input

  Class II

  FDA 510(k) K884532 Active Cleared 18 Nov 1988

• Model #510 Stealth-Plate Dispersive Electrode

  Class II

  FDA 510(k) K922064 Active Cleared 1 Dec 1992

• Model 205 Shock-Trode

  Class II

  FDA 510(k) K910661 Active Cleared 2 May 1991

• Model #810 Stealth-Stim Adult Stimulation Pads

  Class II

  FDA 510(k) K913226 Active Cleared 4 Sep 1991

• Model #100 Shock-Trode Child Defib Pads

  Class II

  FDA 510(k) K911455 Active Cleared 16 Oct 1991

See all devices from Cardiotronics, Inc. →

• What is the primary purpose of the Coordinator, Cable Input device in clinical settings?

  The Coordinator, Cable Input is designed as a peripheral input device specifically for capturing and transmitting cardiac signals. It connects to cardiac monitoring systems to enable remote or ambulatory electrocardiographic (ECG) data acquisition, allowing for long-term patient monitoring in cardiovascular diagnostic settings.

• Is the Coordinator, Cable Input a single-use or reusable device, and what does that mean for maintenance?

  The Coordinator, Cable Input is a reusable medical instrument, meaning it is intended for repeated use after proper cleaning and maintenance. Since it is not sterile, it must be cleaned and disinfected between uses to ensure patient safety and device functionality.

• How is this device regulated by the FDA, and what does that mean for its use in hospitals?

  The Coordinator, Cable Input is regulated under the FDA’s Class II regulatory standards and was authorized through a 510(k) clearance (K914725) with a Traditional review pathway in 1991. This means it has been deemed substantially equivalent to a legally marketed device and is approved for use in cardiovascular diagnostic settings, though hospitals should confirm compliance with their internal protocols and maintenance guidelines.

• What types of cardiac monitoring systems can the Coordinator, Cable Input interface with?

  While the exact compatible systems aren’t detailed in the records, the device is explicitly designed as a peripheral input device for cardiac monitoring systems, meaning it is intended to integrate with existing ECG or telemetry platforms that support remote or ambulatory data acquisition. Clinicians should verify compatibility with their specific monitoring equipment before use.

• Are there any special storage requirements for the Coordinator, Cable Input?

  The records do not specify sterility or environmental storage conditions, but as a reusable medical device, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures. Proper handling and maintenance (e.g., cleaning and calibration) will extend its operational lifespan and ensure accurate signal transmission.