Pikos E 01-B Implantable Pacemaker Pulse-Generator
FDA 510(k)Class III (US FDA 510(k))
Identifiers
- 510(k) Number
- K941937 FDA 510(k)
- FDA Product Code
- DXY FDA 510(k)
Classification
- Device Class
- Class III FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.3610 FDA 510(k)
- Regulation Number
- 870.3610 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESP Substantially Equivalent — Postmarket Surveillance FDA 510(k)
The Pikos E 01-B is an implantable pacemaker pulse-generator, designed to regulate cardiac rhythm in patients with bradycardia or other conduction disorders. As a Class III device, it delivers electrical impulses to the heart to maintain proper pacing and ensure consistent cardiac function, addressing conditions where the natural pacemaker fails.
This device is intended for surgical implantation and is supplied sterile for single-use. It is regulated under FDA 510(k) clearance (K941937) and falls under the medical specialty of cardiovascular devices. The pulse-generator is compatible with MRI environments under specific conditions, as outlined in its labeling, and must be handled and stored according to manufacturer guidelines to preserve sterility and functionality.
Frequently asked questions
What clinical conditions is the Pikos E 01-B pacemaker designed to address in patients?
The Pikos E 01-B is specifically designed to regulate cardiac rhythm in patients with bradycardia or conduction disorders, where the heart’s natural pacemaker fails to maintain proper pacing. It delivers electrical impulses to ensure consistent cardiac function, helping maintain a stable heartbeat in these conditions.
Is the Pikos E 01-B pacemaker intended for reuse, or is it meant to be used only once after opening?
The Pikos E 01-B is supplied sterile and is intended for single-use only. Once opened or implanted, it should not be reused to maintain patient safety and device efficacy.
Can this pacemaker be safely used in patients who require MRI scans, and if so, under what conditions?
Yes, the Pikos E 01-B is compatible with MRI environments under specific conditions outlined in its labeling. However, it must be handled and scanned according to the manufacturer’s guidelines to ensure safety and avoid damage to the device or harm to the patient.
How should the Pikos E 01-B be stored to preserve its sterility and functionality before implantation?
The device must be stored according to Biotronik’s manufacturer guidelines to maintain sterility and functionality. This typically includes keeping it in its original packaging, in a clean and dry environment, and away from extreme temperatures or direct sunlight until ready for use.
What regulatory pathway was followed for the approval of this pacemaker, and what is its classification?
The Pikos E 01-B is a Class III medical device, which requires strict regulatory oversight. It was cleared through the FDA’s 510(k) pathway (K941937) and falls under the cardiovascular specialty category, ensuring it meets rigorous safety and performance standards for implantable pacemakers.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K941937 | Class III | Active |
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Manufacturer
- Manufacturer
- Biotronik, Inc.
Sources (1)
- FDA 510(k) K941937 24 fields · synced Sep 18, 2026