FDA.reportPublic FDA data

Aspire Max 5 Aspiration Catheter 55cm

Primary DI
B090A50552
Brand
Aspire Max 5 Aspiration Catheter 55cm
Company
ZIEN MEDICAL TECHNOLOGIES, INC.
Model
A5-055
Catalog number
A5-055
Device description
ASPIRE MAX 5 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
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K113757000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K113757000ASPIRE MAX ASPIRATION CATHETERControl Medical Technology, LLC2012-02-22QEZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B090A50551PackageHIBCC1In Commercial Distribution
B090A50552PackageHIBCC9In Commercial Distribution
B090A50550PrimaryHIBCC0

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.

Sterilization Methods#

Method table
Method

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
B090C140900XO Cross 14C14-090C14-0902022-06-20
B090C14090H0XO Cross 14C14-090-HC14-090-H2022-06-21
B090C141350XO Cross 14C14-135C14-1352022-06-20
B090C14135H0XO Cross 14C14-135-HC14-135-H2022-06-20
B090C141750XO Cross 14C14-175C14-1752022-06-20
B090C14175H0XO Cross 14C14-175-HC14-175-H2022-06-21
B090C35090H0XO Cross 35C35-090-HC35-090-H2022-10-24
B090C351350XO Cross 35C35-135C35-1352022-06-20
B090C35135H0XO Cross 35C35-135-HC35-135-H2022-10-24
B090C35175H0XO Cross 35C35-175-HC35-175-H2022-10-24
00853989006002XableCathXC-014-065AXC-014-065A2018-09-24
00853989006019XableCathXC-014-090AXC-014-090A2018-09-24
00853989006026XableCathXC-014-145AXC-014-145A2018-09-24
00853989006033XableCathXC-018-065AXC-018-065A2018-09-24
00853989006040XableCathXC-018-090AXC-018-090A2018-09-24
00853989006057XableCathXC-018-145AXC-018-145A2018-09-24
00853989006064XableCathXC-035-065AXC-035-065A2018-09-24
00853989006071XableCathXC-035-090AXC-035-090A2018-09-24
00853989006088XableCathXC-035-145AXC-035-145A2018-09-24
00853989006095XableCathXC-014-065BXC-014-065B2018-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450466995Needle's Eye Snare®Merit Medical Systems, Inc.DXE2026-08-27
00884450466988Needle's Eye Snare®Merit Medical Systems, Inc.DXE2026-08-25
00884450467008Needle's Eye Snare®Merit Medical Systems, Inc.DXE2026-08-25
00885403530534FogartyBecton, Dickinson And CompanyDXE2026-08-14
00885403530541FogartyBecton, Dickinson And CompanyDXE2026-08-14
00885403530558FogartyBecton, Dickinson And CompanyDXE2026-08-14
00885403530572FogartyBecton, Dickinson And CompanyDXE2026-08-14
00885403530589FOGARTYBecton, Dickinson And CompanyDXE2026-08-14
00885403530404FogartyBecton, Dickinson And CompanyDXE2026-07-31
00885403530411FogartyBecton, Dickinson And CompanyDXE2026-07-31
00885403530428FogartyBecton, Dickinson And CompanyDXE2026-07-31
00885403530442FogartyBecton, Dickinson And CompanyDXE2026-07-31
00885403530466FogartyBecton, Dickinson And CompanyDXE2026-07-31
00885403530565FogartyBecton, Dickinson And CompanyDXE2026-07-31
00885403530992FogartyBecton, Dickinson And CompanyDXE2026-07-31
08886483504455Embolectomy CatheterBIOPTIMAL INTERNATIONAL PTE. LTD.DXE2026-05-04
08886483504486Embolectomy CatheterBIOPTIMAL INTERNATIONAL PTE. LTD.DXE2026-05-04
08886483504516Embolectomy CatheterBIOPTIMAL INTERNATIONAL PTE. LTD.DXE2026-05-04
10841156110512PRONTOTELEFLEX INCORPORATEDDXE2026-03-03
20841156110519PRONTOTELEFLEX INCORPORATEDDXE2026-03-03
00850291007697Large Bore 60 cc SyringeInari Medical, Inc.DXE2024-12-20
00763000762353Amplatz Goose Neck™MEDTRONIC, INC.DXE2024-10-27
00763000762360Amplatz Goose Neck™MEDTRONIC, INC.DXE2024-10-27
00763000762377Amplatz Goose Neck™MEDTRONIC, INC.DXE2024-10-27
00763000762384Amplatz Goose Neck™MEDTRONIC, INC.DXE2024-10-27
00763000762391Amplatz Goose Neck™MEDTRONIC, INC.DXE2024-10-27
00763000762407Amplatz Goose Neck™MEDTRONIC, INC.DXE2024-10-27
00763000762414Amplatz Goose Neck™MEDTRONIC, INC.DXE2024-10-27
00763000762421Amplatz Goose Neck™MEDTRONIC, INC.DXE2024-10-27
00763000762438Amplatz Goose Neck™MEDTRONIC, INC.DXE2024-10-27