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Micro Thin-PII, #0523

by Cardiac Pacemakers, Inc.

510(k) K802353

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK802353 Date22 Dec 1980ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DXY
Device Class
Class III
Regulation
21 CFR Part 870.3610
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Micro Thin-PII, #0523 is an Implantable Pacemaker Pulse-Generator, a Class III medical device designed to regulate abnormal heart rhythms by delivering electrical impulses to the heart muscle. It is intended for patients with bradycardia or other conduction disorders requiring chronic pacing support.

This device is supplied as a single-use implantable unit and requires sterile handling prior to surgical implantation. It is regulated under FDA 510(k) clearance (K802353) and falls under the DXY product code, adhering to 21 CFR Part 870.3610 for implantable cardiac devices. Storage and handling must comply with manufacturer guidelines to ensure device integrity before use.

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Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What types of heart conditions is the Micro Thin-PII, #0523 pacemaker designed to treat, and how does it work?

    The Micro Thin-PII, #0523 is specifically designed to address bradycardia (slow heart rate) and other conduction disorders requiring chronic pacing support. It works by delivering controlled electrical impulses to the heart muscle, helping to regulate abnormal heart rhythms and maintain a proper heartbeat when the heart’s natural pacemaker isn’t functioning adequately.

  • Is the Micro Thin-PII, #0523 intended for single-use or can it be reused after implantation?

    The Micro Thin-PII, #0523 is supplied as a single-use implantable device. It must be handled under sterile conditions prior to surgical implantation, and reuse is not recommended or supported by the manufacturer.

  • What storage and handling guidelines should be followed to ensure the device remains intact before use?

    The device must be stored and handled according to the manufacturer’s guidelines to maintain its integrity. While specific instructions aren’t detailed here, compliance with these protocols is critical to ensure the device remains functional and safe for implantation.

  • How was the regulatory pathway for this device determined, and what does the DXY product code indicate?

    The Micro Thin-PII, #0523 was cleared through the FDA’s 510(k) pathway, specifically under the Traditional review process, and is classified as a Class III device. The DXY product code categorizes it as an Implantable Pacemaker Pulse-Generator, aligning with the regulatory framework for cardiac rhythm management devices under 21 CFR Part 870.3610.