Disposable Surgical Extension Cable, Model 4255 and Model 4260

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

510(k) Number

K012392 ↗

FDA Product Code

DSA

Device Class

Class II

Regulation

21 CFR Part 870.2900

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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• Model 3110 Heart Wire & 3110P Pediatric Heart Wire

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• Pace Implant. Lead/Tined/Atrial/J/Model 3290

  Class III

  FDA 510(k) K864153 Active Cleared 6 Jan 1987

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• What is the Disposable Surgical Extension Cable used for?

  The Disposable Surgical Extension Cable, Models 4255 and 4260, is designed for surgical use as an extension cable for medical equipment specifically in cardiovascular procedures.

• Is this cable reusable or single-use?

  This device is supplied as a disposable product and is intended for single-use applications only. It should not be reused on multiple patients or procedures.

• What regulatory approvals does this device have?

  The Disposable Surgical Extension Cable has received FDA 510(k) clearance with authorization number K012392 and is classified under product code DSA, regulated under number 870.2900.

• What models of this extension cable are available?

  The device is available in two models: Model 4255 and Model 4260, both serving as extension cables for medical equipment in cardiovascular procedures.