Thinlith II Pulse Gneerator Model 227-05

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K810386 ↗

FDA Product Code

DXY

Device Class

Class III

Regulation

21 CFR Part 870.3610

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Lifeline Unipolar Lead #487-05

  Class III

  FDA 510(k) K823508 Active Cleared 14 Jan 1983

• Implant Aid Splicing Crimp & Sleeve

  Class III

  FDA 510(k) K813518 Active Cleared 12 Jan 1982

• Veri-Vu Lensometer

  Class I

  FDA 510(k) K791521 Active Cleared 30 Oct 1979

• Implantable Pulse Generator Pacemakers

  Class III

  FDA 510(k) K791568 Active Cleared 19 Sep 1979

• Model 480-01 Pacing Lead

  Class III

  FDA 510(k) K844270 Active Cleared 28 Mar 1985

• GE Lead Adapter, Model 345-01

  Class II

  FDA 510(k) K801040 Active Cleared 30 Jun 1980

See all devices from Intermedics, Inc. →

• What is the primary clinical purpose of the Thinlith II Pulse Generator Model 227-05, and how does it achieve this?

  The Thinlith II Pulse Generator Model 227-05 is designed to regulate cardiac rhythm by delivering electrical impulses to the heart. It is intended for patients with bradycardia or other cardiac conduction disorders who require consistent pacing support to maintain proper heart function. The device achieves this through implanted electrodes that stimulate the heart muscle when natural electrical signals are insufficient.

• Is the Thinlith II Pulse Generator Model 227-05 intended for single-use or reusable applications, and what does this mean for clinical workflows?

  The Thinlith II Pulse Generator Model 227-05 is classified as a reusable device, meaning it is intended for multiple uses after proper sterilization and maintenance. This allows for cost-effective clinical workflows, as the device can be reprocessed and reused for subsequent patients, provided it adheres to sterile implant protocols and FDA-authorized procedures.

• What storage and handling requirements must be followed for the Thinlith II Pulse Generator Model 227-05 to ensure sterility and compliance?

  The Thinlith II Pulse Generator Model 227-05 must be stored and handled according to standard sterile implant protocols, as it is supplied as a sterile medical implant. Compliance is ensured through FDA-authorized procedures, which include maintaining sterility before implantation and following rigorous reprocessing guidelines if reused. This ensures patient safety and regulatory adherence.

• What regulatory pathway was followed for the FDA clearance of the Thinlith II Pulse Generator Model 227-05, and what does this imply for its use?

  The Thinlith II Pulse Generator Model 227-05 received FDA clearance through a Traditional 510(k) pathway (K810386) under regulation 870.3610, with a decision of Substantially Equivalent by the Cardiovascular (CV) Advisory Committee. This implies the device was evaluated for safety and effectiveness compared to a legally marketed predicate and is classified as a Class III device, requiring strict adherence to FDA guidelines for implantation and use in cardiovascular settings.