Millipede70 Aspiration Catheter PMT070137US

GUDID 05391539370241

The Millipede70 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 Millipede70 Aspiration Catheter. For the aspiration source, the Millipede70 Aspiration Catheter is used in conjunction with a compatible aspiration pump with prespecified performance parameters. The aspiration pump is connected using the Perfuze Aspiration Tube Set along with a legally marketed canister and accessories kit.

PERFUZE LIMITED

Thrombectomy suction catheter
Primary Device ID05391539370241
NIH Device Record Key6e711c6b-c167-4799-b526-5039410c6eda
Commercial Distribution StatusIn Commercial Distribution
Brand NameMillipede70 Aspiration Catheter
Version Model Number1.02
Catalog NumberPMT070137US
Company DUNS985715471
Company NamePERFUZE LIMITED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS105391539370241 [Primary]

FDA Product Code

NRYCatheter, Thrombus Retriever

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-09-16
Device Publish Date2025-09-08

Devices Manufactured by PERFUZE LIMITED

05391539370241 - Millipede70 Aspiration Catheter2025-09-16The Millipede70 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 Millipede70 Aspiration Catheter. For the aspiration source, the Millipede70 Aspiration Catheter is used in conjunction with a compatible aspiration pump with prespecified performance parameters. The aspiration pump is connected using the Perfuze Aspiration Tube Set along with a legally marketed canister and accessories kit.
05391539370241 - Millipede70 Aspiration Catheter2025-09-16 The Millipede70 Aspiration Catheter is a sterile single-use device. It consists of the catheter and a rotating hemostasis valve
05391539370050 - Zipline 070 Access Catheter2024-12-09 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 Catheter2024-12-09 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 Catheter2023-12-26 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 Catheter2023-11-10 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 Catheter2023-11-10 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 Catheter2023-11-10 The Millipede 088 Access Catheter consists of the catheter, a rotating hemostasis valve (RHV) and a valve crossing tool. The cat

© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.