CPI LEAD ADAPTERS, MODELS 6017, 6018 AND 6020

• K Number: K041574
• Device Name: CPI LEAD ADAPTERS, MODELS 6017, 6018 AND 6020
• Manufacturer: GUIDANT CORPORATION
• Date Cleared: 2004-07-12 ( 28 days)
• Product Code: DTD
• Regulation Number: 870.3620
• Type: Special
• Panel: CV
• Reference & Predicate Devices: N/A

Intended Use

1. Model 6017: It is designed to join CPI bipolar leads having 3.2mm inline connectors to 5mm (4.75) bifurcated bipolar terminals.
2. Model 6018: It is a single barrel adapter that is designed to join CPI unipolar leads having a 6mm (5.38) unipolar connector to 3.2mm low profile unipolar terminal.
3. Model 6020: It is a single barrel adapter that is designed to join CPI unipolar leads having a 5mm (4.75) unipolar connector to 3.2mm low profile unipolar terminal.

Device Description

Not Found

AI/ML Overview

The provided document is a 510(k) clearance letter for a Pacemaker Lead Adapter. It does not contain information on acceptance criteria or a study proving that the device meets those criteria. The document only confirms that the FDA has found the device to be substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide the requested information.

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.”