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Pikos Lp 01, Pikos Lp E01

FDA 510(k)

Class III (US FDA 510(k))

510(k) K945627

by Biotronik, Inc.

Identifiers

510(k) Number
K945627 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 LP 01 and PIKOS LP E01 are implantable pacemaker pulse-generators, classified under product code DXY. These devices are designed to regulate heart rhythm by delivering electrical impulses to the heart muscle when necessary, ensuring proper cardiac function in patients with bradycardia or other conduction disorders.

These devices are intended for surgical implantation and are regulated under FDA 510(k) clearance (K945627) with postmarket surveillance requirements. Supplied sterile for single-use, they are manufactured by Biotronik, Inc. and comply with regulation 870.3610. The devices are intended for use in cardiovascular settings and are not MRI-safe without specific documentation.

Frequently asked questions

What is the primary purpose of the PIKOS LP 01 and PIKOS LP E01 devices, and how do they function in the body?

The PIKOS LP 01 and PIKOS LP E01 are implantable pacemaker pulse-generators designed to regulate heart rhythm by delivering controlled electrical impulses to the heart muscle when needed. They are specifically intended for patients with bradycardia or conduction disorders, ensuring proper cardiac function by compensating for slow or irregular heartbeats.

Are these devices meant for single-use or can they be reused after implantation?

These devices are supplied sterile and intended for single-use only. They are not designed for reuse, as per standard practice for implantable pacemaker pulse-generators to maintain patient safety and sterility.

What storage conditions should be followed for the PIKOS LP 01 and PIKOS LP E01 before implantation?

While specific storage instructions are not detailed in the provided data, implantable pacemakers like these are typically stored in a clean, dry environment protected from extreme temperatures and moisture. Always refer to the manufacturer’s (Biotronik, Inc.) official packaging or instructions for precise storage guidelines to preserve sterility and functionality.

Are these devices compatible with MRI procedures, and if not, what precautions should be taken?

The PIKOS LP 01 and PIKOS LP E01 are not MRI-safe without specific documentation. Patients with these devices should avoid MRI procedures unless explicitly cleared by the manufacturer or a radiologist, as electromagnetic interference could pose risks to the device’s function or patient safety.

How were these devices reviewed and approved by the FDA, and what regulatory pathway was followed?

These devices underwent a traditional 510(k) review process by the FDA’s Cardiovascular (CV) Advisory Committee, resulting in clearance under 510(k) number K945627. The review was filed in 1994 and cleared in 1996, with ongoing postmarket surveillance requirements to ensure continued safety and performance. The classification is Class III, reflecting their role in life-sustaining or life-supporting functions.

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. Sources consulted: K945627 FDA 510 (k) - PIKOS LP 01 | Biotronik, Inc., PIKOS LP 01, PIKOS LP E01 510 (k) K945627 - FDA.report, PDF K945627 PIKOS LP 01, PIKOS LP E01 - 510kdatabase.net

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Biotronik, Inc.

Sources (1)

  • FDA 510(k) K945627 24 fields · synced Sep 18, 2026