PACING LEAD BIPOLAR ADAPTERS AND EXTENSIONS

• K Number: K010787
• Device Name: PACING LEAD BIPOLAR ADAPTERS AND EXTENSIONS
• Manufacturer: Oscor Inc.
• Date Cleared: 2001-05-22 ( 68 days)
• Product Code: DTD
• Regulation Number: 870.3620

Intended Use

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Device Description

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Predicate Devices

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Reference Devices

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AI/ML (Artificial Intelligence / Machine Learning)

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Therapeutic

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Diagnostic

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SaMD (Software as a Medical Device)

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IVD (In Vitro Diagnostic)

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PCCP (Predetermined Change Control Plan) Authorized

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Overview

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Regulation Number and Section

§ 870.3620 Pacemaker lead adaptor.

(a)
Identification. A pacemaker lead adaptor is a device used to adapt a pacemaker lead so that it can be connected to a pacemaker pulse generator produced by a different manufacturer.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for the Submission of Research and Marketing Applications for Permanent Pacemaker Leads and for Pacemaker Lead Adaptor 510(k) Submissions.”

Summary

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