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A1-A, A1-B, A1-Abp, A1-Mbp, A1-Z, A6-A, A6-B, Peh Pace.

FDA 510(k)

Class II (US FDA 510(k))

510(k) K902889

by Biotronik, GmbH & Co.

Identifiers

510(k) Number
K902889 FDA 510(k)
FDA Product Code
DTD FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.3620 FDA 510(k)
Regulation Number
870.3620 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

This device is a Pacemaker Lead Adaptor, classified under FDA product code DTD. It serves as an intermediary connector between pacemaker leads and pulse generators, facilitating electrical signal transmission in cardiac pacing systems. The adaptors are designed to ensure proper compatibility and secure attachment within implantable cardiac devices.

The A1-A, A1-B, A1-ABP, A1-MBP, A1-Z, A6-A, A6-B, and PEH Pace adaptors are intended for use in clinical settings by trained medical professionals. They are reusable, non-sterile devices and fall under FDA Class II with Special Controls. Authorized under 510(k) clearance K902889, these adaptors were reviewed by the Cardiovascular (CV) Advisory Committee and granted a Substantially Equivalent (SESE) decision in 1990.

Frequently asked questions

What is the primary purpose of these Biotronik Pacemaker Lead Adaptors in a cardiac pacing system?

These adaptors act as intermediary connectors between pacemaker leads and pulse generators, ensuring reliable electrical signal transmission within implantable cardiac devices. They are designed to maintain compatibility and secure attachment between components, which is critical for proper pacing functionality.

Are these adaptors intended for single-use or can they be reused in clinical settings?

These adaptors are explicitly labeled as reusable devices, meaning they are meant for repeated use in clinical settings by trained medical professionals. They are not sterile and should be handled according to facility protocols for reusable medical devices.

What regulatory pathway was followed for FDA clearance of these adaptors, and when was the decision made?

The adaptors were reviewed under the FDA 510(k) pathway with clearance number K902889, granted a Substantially Equivalent (SESE) decision by the Cardiovascular (CV) Advisory Committee on August 23, 1990. The submission was filed in July 1990 and classified under FDA product code DTD as a Class II device with Special Controls.

Which specific models of Biotronik Pacemaker Lead Adaptors are included in this authorization?

The authorization covers the following models: A1-A, A1-B, A1-ABP, A1-MBP, A1-Z, A6-A, A6-B, and PEH PACE. Each model is designed to ensure compatibility with different pacemaker lead and pulse generator configurations in cardiac pacing systems.

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: A1-a,A1-b,A1-abp,A1-mbp,A1-z,A6-a,A6-b,Peh Pace., K902889 FDA 510 (k) - A1-A | Biotronik, GmbH & Co., K902889 FDA 510 (k) - A1-A | Biotronik, GmbH & Co., A1-A,A1-B,A1-ABP,A1-MBP,A1-Z,A6-A,A6-B,PEH PACE. 510 (k) K902889 - FDA ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Biotronik, GmbH & Co.

Sources (1)

  • FDA 510(k) K902889 24 fields · synced Oct 6, 2026