Cook Pacemaker Corp. 327T Series R Unipolar Cardi

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

510(k) Number

K853590 ↗

FDA Product Code

DXY

Device Class

Class III

Regulation

21 CFR Part 870.3610

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• 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

• 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

• Model 325T Programmable Pulse Generator

  Class III

  FDA 510(k) K812358 Active Cleared 29 Oct 1981

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• What types of patients is this pacemaker designed to support, and how does it differ from bipolar models?

  The Cook Pacemaker Corp. 327T Series R Unipolar Cardi is specifically designed for patients requiring temporary or permanent pacing support due to conditions like bradycardia or conduction disorders. Unlike bipolar models, this unipolar device delivers electrical impulses using a single electrode, which may simplify implantation but requires careful consideration of lead placement and tissue interaction. The unipolar design is ideal for clinicians who prefer its straightforward configuration for consistent cardiac rhythm regulation.

• Is this device intended for reuse, or is it meant to be implanted once and discarded?

  This device is explicitly supplied sterile and intended for single-use implantation only. It must be handled under sterile surgical protocols, as it is not designed for reuse. After implantation, it should be considered a permanent implant, though the pulse-generator itself is not meant to be removed or reused.

• What storage or handling precautions should be taken before implantation, given its sterile packaging?

  Since the Cook Pacemaker Corp. 327T Series R is supplied sterile, it must be stored according to sterile surgical protocols to maintain its integrity. The packaging should remain unopened until immediate use in a controlled clinical environment. Avoid exposure to moisture, extreme temperatures, or contamination, as these could compromise sterility and device functionality.

• What regulatory pathway was followed for FDA clearance, and how does this affect its use in clinical settings?

  This device received FDA clearance through the Traditional 510(k) review pathway under the Cardiovascular advisory committee, with a decision of *Substantially Equivalent* (SESE). This means it was compared to a legally marketed predicate device and deemed safe and effective for its intended use. Clinically, this clearance ensures it meets FDA standards for implantable pacemaker pulse-generators (regulated under 21 CFR 870.3610), but it does not imply compatibility with MRI—no safety information regarding MRI exposure is provided.