Insertion Kit with 8Fr. 6” (15cm) Introducer for Use with the SENSATION PLUS 8Fr 50cc IAB

Insertion Kit with 8Fr. 6” (15cm) Introducer for Use with the SENSATION PLUS 8Fr 50cc IAB
Insertion Kit with 8Fr. 6” (15cm) Introducer for Use with the SENSATION PLUS 8Fr - 0884-00-0019-23

A collection of nonimplantable, invasive devices intended to provide percutaneous vascular access to enable introduction of a catheter (not included) into the vascular system. It includes a non-steerable introducer sheath with an inner obturator/dilator, and typically an additional access device(s) [e.g., guidewire, introducer needle, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually to enable arterial access. This is a single-use device.

No Data Available

• Catheter Gauge: 8 French

Device Sterile: True

Sterilization Prior To Use: True

Sterilization Methods:

• Ethylene Oxide

Code: DSP

Device Name: System, Balloon, Intra-Aortic And Control

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: N

Target Area: N/A

Regulation Number: 870.3535

Third Party Flag: N

Medical Specialty: CV

Device Id: 10607567108599

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