Millipede 088 Access Catheter

Primary DI
05391539370197
Brand
Millipede 088 Access Catheter
Company
PERFUZE LIMITED
Model
2.01
Catalog number
PMA088121US
Device description
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, 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.
Published
2026-03-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
QJPCatheter, Percutaneous, Neurovasculature

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QJPCatheter, Percutaneous, NeurovasculatureCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K242504000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242504000Millipede 088 Access Catheter; Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube SetPerfuze, Ltd.2024-09-20NRY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05391539370197PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05391539370197053915393701975391539370197

GMDN Terms#

Term, Definition table
TermDefinition
Vascular guide-catheter, single-useA flexible tube intended to be used for the percutaneous transluminal passage and placement of a diagnostic/interventional catheter, lead (e.g., pacing lead, balloon dilatation catheter), needle or guidewire through its lumen(s), within the vascular system. It may be rigid or flexible, non-steerable or steerable, single or multiple lumen(s), and the distal section can have a variety of preformed shapes. It is not intended solely for infusion nor to access superselective small vessels, and does not include a transseptal needle. A percutaneous introduction set, shaft visualization electrodes, or haemostatic valve may be supplied with the guide-catheter. This is a single-use device.

Regulatory Flags#

DUNS number
985715471
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05391539370296Millipede88 Catheter2.1PMT088120US2026-08-21
05391539370173Millipede88 Access Catheter2.1PMA088121US2026-07-15
05391539370050Zipline 070 Access Catheter1.0PZA070158US2024-11-30
05391539370067Zipline 088 Access Catheter1.0PZA088147US2024-11-30
05391539370142Millipede 088 Access Catheter2.0PMA088121US2023-12-18
05391539370005Millipede 088 Access Catheter1.1MA088117US2023-11-02
05391539370111Millipede 088 Access Catheter1.2PMA088120US2023-11-02
05391539370241Millipede70 Aspiration Catheter1.02PMT070137US2025-09-08
05391539370180Millipede 070 Aspiration Catheter 1.01PMT070137US2025-06-24
05391539370074Aspiration Tube Set 1.0PA110100US2023-11-02
05391539370098Millipede 070 Aspiration Catheter1.0PMT070137US2023-11-02

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