Zipline 088 Access Catheter

Primary DI
05391539370067
Brand
Zipline 088 Access Catheter
Company
PERFUZE LIMITED
Model
1.0
Catalog number
PZA088147US
Device description
The Zipline 088 Access Catheter is a single-use device designed to deliver large-bore catheters to the neurovasculature using standard endovascular techniques. It is supplied sterile and nonpyrogenic. Zipline 088 is designed for use with outer catheters with 0.088” or larger internal diameter. During use, the Zipline 088 Access Catheter is advanced over a guidewire to the desired location in the neurovasculature. An outer catheter is then advanced over the Zipline 088 Access Catheter to the desired location. The Zipline 088 Access Catheter is a single lumen, variable stiffness catheter. It has a tapered flexible tip and a radiopaque marker at its distal end. Proximal to the tapered section is a “bulb” and a radiopaque coil to facilitate bulb visualization under fluoroscopy. The outer diameter of the bulb is designed to closely match the inner diameter of outer catheters, thereby minimizing the gap between the two catheters during navigation. The Zipline 088 Access Catheter has a hydrophilic coating on the outer surface of the distal end to enhance tracking through the vasculature. A luer fitting located on the catheter hub is used for attachment of ancillary devices. A continuous internal lumen spanning from the distal tip to the proximal hub accommodates guidewires up to 0.018” in diameter.
Published
2024-11-30
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
K240711000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240711000Zipline Access CatheterPerfuze, Ltd.2024-10-17QJP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05391539370067PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05391539370067053915393700675391539370067

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
05391539370197Millipede 088 Access Catheter2.01PMA088121US2026-03-24
05391539370050Zipline 070 Access Catheter1.0PZA070158US2024-11-30
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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05391539370173Millipede88 Access CatheterPERFUZE LIMITEDQJP2026-07-15
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00850014025397APRO 45 Intermediate CatheterAlembic, LLCQJP2026-03-25
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00850074235101Toro 88 Superbore CatheterToro Neurovascular, Inc.QJP2026-02-16
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0086001030637687 NeuGlide+ CatheterPIRAEUS MEDICAL INC.QJP2026-02-02
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