Miniflex Model 340, 341, and 342 Pulse Generators

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

510(k) Number

K953417 ↗

FDA Product Code

DXY

Models / Variants

340

341

342 Pulse Generators

Device Class

Class III

Regulation

21 CFR Part 870.3610

Advisory Committee

Cardiovascular

FDA Decision

ST

• Needle's Eye Snare

  Class II

  FDA 510(k) K961992 Active Cleared 27 Dec 1996

• Model P In-Line Bipolar Endocardial Tined Lead

  Class III

  FDA 510(k) K915188 Active Cleared 11 Sep 1992

• Cook Pacemaker Corp. 327T Series R Unipolar Cardi

  Class III

  FDA 510(k) K853590 Active Cleared 23 Oct 1985

• Model F Unipolar Endocardial Lead

  Class III

  FDA 510(k) K832255 Active Cleared 12 Aug 1983

• Model 325D Unipolar Cardiac Pulse Gen

  Class III

  FDA 510(k) K822904 Active Cleared 15 Oct 1982

• Model 329T Programmable, Bipolar Cardi

  Class III

  FDA 510(k) K832893 Active Cleared 4 Oct 1983

See all devices from Cook Pacemaker Corp. →

• Are the Miniflex Model 340, 341, and 342 Pulse Generators reusable or intended for single-use only?

  The Miniflex Model 340, 341, and 342 Pulse Generators are supplied sterile and explicitly designed for single-use only after surgical implantation. This aligns with standard practices for implantable cardiac devices to ensure patient safety and sterility.

• How are the Miniflex Model 340, 341, and 342 Pulse Generators regulated by the FDA, and what does that mean for their use?

  These devices are classified as Class III under FDA regulations due to their role in life-sustaining or supporting functions. They received FDA 510(k) clearance (K953417) under the *Traditional* review pathway, meaning they were deemed substantially equivalent to a legally marketed predicate device. This clearance confirms they meet FDA safety and effectiveness standards for use as implantable pacemaker pulse-generators.

• What distinguishes the Miniflex Model 340, 341, and 342 Pulse Generators from each other, and how are they identified?

  The models (340, 341, and 342) are individually identifiable by their model number, though the provided data does not specify functional or technical differences between them. Each model adheres to the same regulatory standards for implantable cardiac devices, including MRI safety considerations (per regulation 870.3610).

• What storage or handling precautions should be taken with the Miniflex Model 340, 341, and 342 Pulse Generators before implantation?

  Since these devices are sterile upon supply, they must be stored in their original packaging until use to maintain sterility. The packaging should be kept dry, protected from physical damage, and away from extreme temperatures or direct sunlight. Always follow manufacturer guidelines for unpacking and preparing the device for surgical implantation.

• Are these devices compatible with MRI procedures, and what safety considerations apply?

  The Miniflex Model 340, 341, and 342 Pulse Generators comply with FDA regulation 870.3610, which outlines MRI safety standards for implantable cardiac devices. This means they are designed with MRI safety in mind, but specific MRI compatibility details (e.g., safe scan parameters) should be verified with the manufacturer’s instructions before any MRI procedure to ensure patient safety.