Millipede 070 Aspiration Catheter PMT070137US

GUDID 05391539370098

The Millipede 070 Aspiration Catheter is a sterile single-use device. It consists of the catheter and a rotating hemostasis valve (RHV). The catheter is a single lumen, 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 RHV is assembled onto the hub of the catheter and is used to maintain hemostasis during infusion of saline and contrast agent and insertion of devices into the Millipede 070 Aspiration Catheter. For the aspiration source, the Millipede 070 Aspiration Catheter is used in conjunction with an compatible aspiration pump with prespecified performance parameters that is connected using the Perfuze Aspiration Tube Set along with a legally marketed canister and accessories kit.

PERFUZE LIMITED

Thrombectomy suction catheter

• Primary Device ID: 05391539370098
• NIH Device Record Key: d59dd1c0-f6e3-40d6-8163-26cf1043143f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Millipede 070 Aspiration Catheter
• Version Model Number: 1.0
• Catalog Number: PMT070137US
• 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	05391539370098 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232524

FDA Product Code

• NRY: Catheter, Thrombus Retriever

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: 2023-11-10
• Device Publish Date: 2023-11-02

Devices Manufactured by PERFUZE LIMITED

• 05391539370050 - Zipline 070 Access Catheter: 2024-12-09 The Zipline 070 Access Catheter is a single-use device designed to deliver large-bore catheters to the neurovasculature using st
• 05391539370067 - Zipline 088 Access Catheter: 2024-12-09 The Zipline 088 Access Catheter is a single-use device designed to deliver large-bore catheters to the neurovasculature using st
• 05391539370142 - Millipede 088 Access Catheter: 2023-12-26 The Millipede 088 Access Catheter consists of the catheter, a rotating hemostasis valve (RHV) and a valve crossing tool. The cat
• 05391539370005 - Millipede 088 Access Catheter: 2023-11-10 The Millipede 088 Access Catheter consists of the catheter, a rotating hemostasis valve (RHV) and a valve crossing tool. The cat
• 05391539370074 - Aspiration Tube Set: 2023-11-10 The Perfuze Aspiration Tube Set is a sterile, single-use device consisting of a single flexible braided tube. The tube has a rot
• 05391539370098 - Millipede 070 Aspiration Catheter: 2023-11-10The Millipede 070 Aspiration Catheter is a sterile single-use device. It consists of the catheter and a rotating hemostasis valve (RHV). The catheter is a single lumen, 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 RHV is assembled onto the hub of the catheter and is used to maintain hemostasis during infusion of saline and contrast agent and insertion of devices into the Millipede 070 Aspiration Catheter. For the aspiration source, the Millipede 070 Aspiration Catheter is used in conjunction with an compatible aspiration pump with prespecified performance parameters that is connected using the Perfuze Aspiration Tube Set along with a legally marketed canister and accessories kit.
• 05391539370098 - Millipede 070 Aspiration Catheter: 2023-11-10 The Millipede 070 Aspiration Catheter is a sterile single-use device. It consists of the catheter and a rotating hemostasis valv
• 05391539370111 - Millipede 088 Access Catheter: 2023-11-10 The Millipede 088 Access Catheter consists of the catheter, a rotating hemostasis valve (RHV) and a valve crossing tool. The cat