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Micro Thin-DII, #0521

by Cardiac Pacemakers, Inc.

510(k) K802352

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 NumberK802352 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  • Withdrawn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-DII, #0521 is an Implantable Pacemaker Pulse-Generator, a Class III medical device designed to regulate heart rhythm by delivering electrical impulses to the heart muscle. It is intended for patients with bradycardia or other conduction disorders requiring chronic pacing support, functioning as a standalone or part of a pacing system to maintain proper cardiac function.

This device is supplied sterile and intended for single-use implantation, though it may be reusable in specific clinical settings as determined by the manufacturer. It is classified under FDA regulation 870.3610 and holds a Traditional 510(k) clearance (K802352) under the Cardiovascular advisory committee. The device is not explicitly noted for MRI safety in the provided data, and storage conditions should follow manufacturer guidelines to preserve sterility and functionality.

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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 patients is the Micro Thin-DII, #0521 pacemaker designed to support, and how does it function?

    The Micro Thin-DII, #0521 is designed for patients with bradycardia or conduction disorders requiring chronic pacing support. It functions as an implantable pulse-generator that delivers electrical impulses to the heart muscle to regulate heart rhythm, either as a standalone device or as part of a larger pacing system to maintain proper cardiac function.

  • Is the Micro Thin-DII, #0521 intended for single-use or can it be reused in clinical settings?

    The device is supplied sterile and intended for single-use implantation. However, the manufacturer may allow for reuse in specific clinical settings, so it’s important to follow their guidelines to ensure proper functionality and sterility.

  • What regulatory pathway was followed for the FDA clearance of this device, and which advisory committee was involved?

    The Micro Thin-DII, #0521 received a Traditional 510(k) clearance (K802352) under the Cardiovascular advisory committee, with a decision of Substantially Equivalent (SESE) in 1980. This means it was deemed comparable to a legally marketed predicate device.

  • Are there any specific storage instructions mentioned for this device to maintain its sterility and functionality?

    The provided data does not specify exact storage conditions, but the manufacturer’s guidelines should be followed to preserve sterility and ensure the device remains functional. Always adhere to the instructions provided by Cardiac Pacemakers, Inc.