Millipede 088 Access Catheter PMA088121US

GUDID 05391539370142

The Millipede 088 Access Catheter consists of the catheter, a rotating hemostasis valve (RHV) and a valve crossing tool. The catheter, RHV and valve crossing tool are provided sterile. They are sterilized by ethylene oxide (EO). The Millipede 088 Access Catheter is a single lumen, coil-reinforced, variable stiffness catheter. The distal segment has a hydrophilic coating for navigation through the vasculature. The catheter has a radiopaque marker located at its distal end for visualization under fluoroscopy. The valve crossing tool is used to open the valve of the access sheath and to facilitate insertion of the Millipede 088 Access Catheter through the access sheath without damage. The RHV is assembled onto the hub of the Millipede 088 Access Catheter and is used to maintain hemostasis during infusion of saline and contrast agent and insertion of other devices through the Millipede 088 Access Catheter The Millipede 088 Access Catheter is indicated for use in facilitating the insertion and guidance of microcatheters into a selected blood vessel in the neurovasculature.

PERFUZE LIMITED

Vascular guide-catheter, single-use

• Primary Device ID: 05391539370142
• NIH Device Record Key: 7aa75ad7-9adb-4c1e-a0d3-292ef9e49db5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Millipede 088 Access Catheter
• Version Model Number: 2.0
• Catalog Number: PMA088121US
• Company DUNS: 985715471
• Company Name: PERFUZE LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05391539370142 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233648

FDA Product Code

• QJP: Catheter, Percutaneous, Neurovasculature

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-12-26
• Device Publish Date: 2023-12-18

On-Brand Devices [Millipede 088 Access Catheter]

• 05391539370111: The Millipede 088 Access Catheter consists of the catheter, a rotating hemostasis valve (RHV) an
• 05391539370005: The Millipede 088 Access Catheter consists of the catheter, a rotating hemostasis valve (RHV) an
• 05391539370142: The Millipede 088 Access Catheter consists of the catheter, a rotating hemostasis valve (RHV) an