FDA.reportPublic FDA data

Aspire Max 6 Aspiration Catheter 135cm

Primary DI
B090A61352
Brand
Aspire Max 6 Aspiration Catheter 135cm
Company
ZIEN MEDICAL TECHNOLOGIES, INC.
Model
A6-135
Catalog number
A6-135
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
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
QEZAspiration Thrombectomy Catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXECatheter, EmbolectomyCardiovascular2
QEZAspiration Thrombectomy CatheterCardiovascular2

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
B090A61351PackageHIBCC1In Commercial Distribution
B090A61352PackageHIBCC9In Commercial Distribution
B090A61350PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Thrombectomy suction catheterA sterile flexible tube designed for the percutaneous, transluminal disruption and removal of clotted blood (i.e., a thrombus or thromboembolus) or other formed elements causing vascular obstruction in native and stented blood vessels, native and synthetic bypass grafts, and/or haemodialysis access grafts, through suction (aspiration) typically achieved with the use of an included syringe(s) attached to the proximal end of the catheter, or connection to a dedicated suction pump system. Collection baskets may also be included to obtain filtered blood specimens for analyses. 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

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10850049994863Syntervention 4008-2032025-09-26
10850049994870Syntervention 4008-3032025-09-26
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10850049994894Syntervention 4008-2052025-09-26
10850049994900Syntervention 4008-3052025-09-26
10850049994917Syntervention 4008-4052025-09-26
10850049994924Syntervention 4008-2072025-09-26
10850049994931Syntervention 4008-3072025-09-26
10850049994948Syntervention 4008-4072025-09-26
10850049994955Syntervention 4008-2092025-09-26
10850049994962Syntervention 4008-3092025-09-26
10850049994979Syntervention4007-4092025-09-26

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