Microthin-Pii Bipolar Pulse Gen. #0623

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

510(k) Number

K803034 ↗

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

• 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

• Micro Thin-PII, #0523

  Class III

  FDA 510(k) K802353 Active Cleared 22 Dec 1980

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• Is the Microthin-PII Bipolar Pulse Generator #0623 designed for reuse or is it intended for single-use implantation only?

  The Microthin-PII Bipolar Pulse Generator #0623 is explicitly designed for single-use implantation. This is stated directly in the device description, which specifies it is intended for one-time use after implantation.

• How is the Microthin-PII Bipolar Pulse Generator #0623 supplied, and is it sterile upon receipt?

  The device is supplied sterile and ready for use, as noted in the description. Since it is an implantable medical device, sterility is a critical requirement to prevent infection during cardiovascular procedures.

• What regulatory pathway was used for FDA clearance of this device, and what does that mean for its approval status?

  The Microthin-PII Bipolar Pulse Generator #0623 was cleared via the FDA 510(k) pathway under the traditional review process, with a decision of *Substantially Equivalent* (SESE). This means the FDA determined it is as safe and effective as a legally marketed predicate device, though it remains a Class III device due to its life-sustaining role. The clearance number is K803034.

• What medical specialty is primarily responsible for the use of this device, and what type of patients would it typically serve?

  The device falls under the Cardiovascular medical specialty, as indicated by its regulatory filings. It is intended for patients requiring cardiac rhythm regulation, specifically those with bradycardia or other conditions necessitating an implantable pacemaker to deliver electrical impulses to the heart.

• Does this device have multiple models or sizes, or is it a single-unit design?

  The provided data does not specify multiple models or sizes for the Microthin-PII Bipolar Pulse Generator #0623—only the specific unit number (#0623) is mentioned. However, the associated FEI numbers (e.g., 3002807576) suggest it may have been distributed in various lot or batch configurations, but no size or model variations are detailed in the description.