Microthin-Pii Bipolar Pulse Gen. #0621

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

510(k) Number

K803035 ↗

FDA Product Code

DXY

Device Class

Class III

Regulation

21 CFR Part 870.3610

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Acuity Universal Cutter

  Class II

  FDA 510(k) K080154 Active Cleared 20 Mar 2008

• Pacemaker Programmer #2010

  Class III

  FDA 510(k) K811217 Active Cleared 20 Jul 1981

• Microthin-Pii Bipolar Pulse Gen. #0623

  Class III

  FDA 510(k) K803034 Active Cleared 22 Dec 1980

• Astra 2, 3, 4 and 6: Chip Revision

  Not classified

  FDA 510(k) K863000 Active Cleared 19 Aug 1986

• Command Ultra I Implantable Pacemaker Pulse-Generator

  Class III

  FDA 510(k) K831161 Active Cleared 15 Jun 1983

• Elgiloy Stylet

  Class II

  FDA 510(k) K770243 Active Cleared 14 Feb 1977

See all devices from Cardiac Pacemakers, Inc. →

• What clinical conditions is the Microthin-PII Bipolar Pulse Generator intended to treat?

  The Microthin-PII Bipolar Pulse Generator is designed to regulate cardiac rhythm for patients with bradycardia or conduction disorders by delivering programmable electrical impulses to the heart. It ensures consistent cardiac output, which is critical for maintaining stable heart function in patients requiring artificial pacing.

• Is this device intended for single-use or can it be reused after implantation?

  The Microthin-PII Bipolar Pulse Generator is supplied as a reusable, implantable unit. It is intended for long-term use within patients and must be handled according to sterile procedures prior to implantation, as it is not designed for single-use.

• What storage and handling precautions should be taken for this device?

  The device must be stored and handled in compliance with the manufacturer’s guidelines to maintain its functionality and sterility. Since it is implantable and requires sterile procedures before use, proper storage conditions are essential to prevent contamination or damage.

• Is this device compatible with MRI procedures?

  No, the Microthin-PII Bipolar Pulse Generator is explicitly stated as *not* MRI-safe. This means it should not be exposed to MRI environments, as the magnetic fields could interfere with its operation or cause harm to the patient.

• What regulatory pathway was followed for this device’s approval, and what does that mean for its safety and equivalence?

  The device was cleared through the FDA’s 510(k) process (K803035) under a *Traditional* review pathway, with a decision classification of *Substantially Equivalent* to a predicate device. This means it was determined to have the same intended use and technological characteristics as a previously approved device, ensuring its safety and effectiveness are supported by prior regulatory findings.