KIT 5866-9M ADAPTER FORMSCAPE NO CE

KIT 5866
NA - 5866-9M

An implantable device used to provide a functional and modified connection between existing pacing leads (e.g., IS-1 leads) and an implantable pacing/defibrillation device (e.g., pacemaker, defibrillator). It typically consists of a small connector block to enable attachment to the pacing leads (i.e., when they do not meet connection design) and extension leads to increase the reach of the pacing leads. During implantation the surgeon uses a tool to tighten the connections (e.g., a Hex wrench), and a medical adhesive to seal the connections from body fluid contamination. This device facilitates the implantation of the pacing device and/or is useful if two leads need to be implanted.

No Data Available

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: DTD

Device Name: Pacemaker Lead Adaptor

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: CV

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: Y

Target Area: N/A

Regulation Number: 870.3620

Third Party Flag: N

Medical Specialty: CV

Device Id: 00613994897947

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A