Insertion Kit with 6” (15cm) Introducer for use with Linear 7.5Fr. 25cc IAB
Insertion Kit with 6” (15cm) Introducer for use with Linear 7.5Fr. 25cc IAB - 0884-00-0019-12
Device Description
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.
Environmental Conditions
No Data Available
Device Sizes
- Catheter Gauge: 7.5 French
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: True
Sterilization Methods:
- Ethylene Oxide
Product Codes
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 IdentifiersDevice Id: 10607567106632
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
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