FDA.reportPublic FDA data

Aspire Max 6 Aspiration Catheter 55cm

Primary DI
B090A60550
Brand
Aspire Max 6 Aspiration Catheter 55cm
Company
Zien Medical Technologies, LLC
Model
A6-055
Catalog number
A6-055
Device description
ASPIRE MAX 6 Mechanical Thrombectomy Systems™ for removal of fresh, soft emboli and thrombi from vessels in the peripheral vasculature.
Published
2017-08-17
Public version status
Update
Distribution status
Not 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
DXECatheter, Embolectomy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXECatheter, EmbolectomyCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B090A60551PackageHIBCC1Not in Commercial Distribution
B090A60552PackageHIBCC9Not in Commercial Distribution
B090A60550PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose syringe, single-useA sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used for injection/withdrawal of fluids/gas (e.g., medication) to/from a medical device or the body (i.e., capable of both); a needle is not included. It is intended for various medical applications and is not dedicated to medication administration. At the distal end of the barrel is a male connector (typically Luer-lock/slip type) for the attachment to a hypodermic needle or an administration set. It is typically made of plastic and silicone materials and may have anti-stick plunger allowing smooth plunger movement, either manually or by a syringe pump. This is a single-use device.

Regulatory Flags#

DUNS number
017535668
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
00850068519361SAM MedicalIO845-1P2026-09-03
00850068519378SAM MedicalIO846-1P2026-09-03
00850068519385SAM MedicalIO847-1P2026-09-03
10853624005008PenBlade Safety Scalpel#10 BladePB-M-102020-09-21
10853624005015PenBlade Safety Scalpel#11P BladePB-M-11P2020-09-21
10853624005022PenBlade Safety Scalpel#15 BladePB-M-152020-09-21
B0902P0130B0Knight Microcatheter2P0-130-B2P0-130-B2024-04-30
B0902P0130S0Knight Microcatheter2P0-130-S2P0-130-S2024-04-30
B0905XGW0SPINR5X-GW5X-GW2022-07-21
B090A110600Control 11F Mechanical Thrombectomy System, 60cmA11-060A11-0602022-06-29
B090A110900Control 11F Mechanical Thrombectomy SystemA11-090A11-0902022-06-29
B090A50550Aspire Max 5 Aspiration Catheter 55cmA5-055A5-0552017-08-17
B090A51350Control 5F Mechanical Thrombectomy System 135cmA5-135A5-1352017-08-17
B090A61350Control 6F Mechanical Thrombectomy System 135cmA6-135A6-1352017-08-17
B090A70900Control 7F Mechanical Thrombectomy SystemA7-090A7-0902022-06-29
B090A90600Control 9F Mechanical Thrombectomy System, 60cmA9-060A9-0602022-06-29
B090A90900Control 9F Mechanical Thrombectomy System, 90cmA9-090A9-0902022-06-29
B090ARXLP60Control RX-LP Mechanical Thrombectomy System, 136cmARX-LP6ARX-LP62017-08-17
B090ASP10010Control RX-LP Mechanical Thrombectomy SystemASP-1001ASP-10012023-04-26
B090ASP10130Control 7F Mechanical Thrombectomy SystemASP-1013ASP-10132023-05-03

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Primary DI, Brand, Company table
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00850076916046LMI ARTERIAL EMBOLECTOMY CATHETER (EDW)LUCAS MEDICAL INCDXE2026-09-18
00850076916053LMI ARTERIAL EMBOLECTOMY CATHETER (EDW)LUCAS MEDICAL INCDXE2026-09-18
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00850076916077LMI ARTERIAL EMBOLECTOMY CATHETER (EDW)LUCAS MEDICAL INCDXE2026-09-18
00850076916084LMI ARTERIAL EMBOLECTOMY CATHETER (EDW)LUCAS MEDICAL INCDXE2026-09-18
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