Pulse Generator, Sorin Model DL-1

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

Full name

Generator, Pulse, Sorin Model Dl-1

510(k) Number

K780897 ↗

FDA Product Code

DXY

Device Class

Class III

Regulation

21 CFR Part 870.3610

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K802847 Active Cleared 16 Dec 1980

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  FDA 510(k) K894826 Active Cleared 28 Feb 1990

• Q220F Carditomy Reservoir/Modified

  Class II

  FDA 510(k) K790635 Active Cleared 18 Apr 1979

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  Class II

  FDA 510(k) K812173 Active Cleared 18 Aug 1981

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  Class II

  FDA 510(k) K823273 Active Cleared 5 Jan 1983

• Physiological Pressure Transducer #900

  Class II

  FDA 510(k) K820342 Active Cleared 4 Mar 1982

See all devices from Bentley Laboratories, Inc. →

• What is the primary clinical purpose of the Sorin Model DL-1 Pulse Generator and how does it function in patients?

  The Sorin Model DL-1 Pulse Generator is designed to treat patients with bradycardia or cardiac conduction disorders by delivering consistent electrical impulses to regulate heart rhythm. It is intended for permanent implantation to compensate when the heart’s natural electrical system fails, ensuring proper cardiac function through controlled pacing.

• Is this device intended for reuse or single-use, and how should it be handled before implantation?

  The Sorin Model DL-1 is supplied sterile and intended for single-use only after implantation. It must be handled in a controlled clinical setting by qualified healthcare professionals, adhering to sterile procedures to maintain its integrity before use.

• What regulatory pathway was followed for this device, and what does its classification as a Class III device imply?

  The Sorin Model DL-1 received a Traditional 510(k) clearance (K780897) under FDA regulation 870.3610, classified as substantially equivalent to a predicate device. As a Class III device, it was reviewed by the Cardiovascular (CV) Advisory Committee due to its role in life-sustaining or supporting functions, ensuring rigorous evaluation of safety and effectiveness.

• Is this device still actively manufactured or supported by the manufacturer?

  The Sorin Model DL-1 is a legacy device with no active manufacturing or regulatory updates since its 1978 clearance. While it remains listed in FDA registries, it is no longer produced or supported by Bentley Laboratories, Inc., and should be used with caution in clinical settings.