FDA.reportPublic FDA data

AXS VECTA 74

Primary DI
07613327459265
Brand
AXS VECTA 74
Company
Stryker Corporation
Model
INC-11597-132
Catalog number
INC-11597-132
Device description
Intermediate Catheter
Published
2019-02-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DQYCatheter, percutaneous
NRYCATHETER, THROMBUS RETRIEVER
QJPCatheter, Percutaneous, Neurovasculature

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQYCatheter, PercutaneousCardiovascular2
NRYCatheter, Thrombus RetrieverCardiovascular2
QJPCatheter, Percutaneous, NeurovasculatureCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K181354000
K190212000
K190833000
K191768000
K200206000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181354000074 Zenith Flex SystemInneuroco, Inc.2018-10-25NRY
K190212000AXS Vecta Aspiration SystemStryker Neurovascular2019-04-24NRY
K190833000AXS Vecta Aspiration CatheterStryker Neurovascular2019-12-15DQY
K191768000AXS Vecta Aspiration SystemStryker Neurovascular2019-07-30NRY
K200206000AXS Vecta 71 Intermediate Catheter, AXS Vecta 74 Intermediate CatheterStryker Neurovascular2020-02-27QJP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613327459265PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327459265076133274592657613327459265

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length132Centimeter
Lumen/Inner Diameter0.074Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in cool, dry, dark place.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(855)916-3876NVCustomerService@stryker.com

Regulatory Flags#

DUNS number
042405446
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04546540434364SpinePlex04062020000406-202-0002016-06-30
07613154599097NA59200002015920-000-2012016-09-23
07613154599103NA59200002025920-000-2022018-09-24
07613154599110NA59200002035920-000-2032018-09-24
07613154599134NA59200002055920-000-2052018-09-24
07613154599141NA59200002065920-000-2062018-09-24
07613154599158NA59200002075920-000-2072018-09-24
07613154599165NA59200002085920-000-2082018-09-24
07613154599172NA59200002095920-000-2092018-09-24
07613154599189NA59200003015920-000-3012018-09-24
07613154599196NA59200003025920-000-3022018-09-24
07613154599202NA59200003035920-000-3032018-09-24
07613154599219NA59200003045920-000-3042018-09-24
07613154599226NA59200003055920-000-3052018-09-24
07613154599233NA59200003065920-000-3062018-09-24
07613154599240NA59200003075920-000-3072018-09-24
07613154615513NA59200003095920-000-3092018-09-24
07613252254430VertaPlex04066220000406-622-0002016-09-23
07613327141771SpinePlex040622200004062220002016-09-23
07613327141788SpinePlex04062020100406-202-0102016-09-23

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810024671953SSPC NXT Delivery CatheterCENTERPOINT SYSTEMS LLCDQY2026-06-01
08718481740330Guidion ShortIMDS Operations B.V.DQY2026-06-01
08718481740347FlowGuideIMDS Operations B.V.DQY2026-06-01
00857545008295Lynx Aspiration Catheter SystemQ'APEL MEDICAL LLCNRY2026-05-29
00857545008301Lynx Aspiration Catheter SystemQ'APEL MEDICAL LLCNRY2026-05-29
00857545008318Lynx Aspiration Catheter SystemQ'APEL MEDICAL LLCNRY2026-05-29
00857545008325Lynx Aspiration Catheter SystemQ'APEL MEDICAL LLCNRY2026-05-29
00857545008332Lynx Aspiration Catheter SystemQ'APEL MEDICAL LLCNRY2026-05-29
07613327623338AXS LiftStryker CorporationDQY2025-03-04
07613327623352AXS LiftStryker CorporationQJP2025-03-04
07613327623376AXS LiftStryker CorporationDQY2025-03-04
07613327623390AXS LiftStryker CorporationQJP2025-03-04
07613327519358AXS VECTA 46Stryker CorporationNRY2021-12-17
07613327519365AXS VECTA 46Stryker CorporationNRY2021-12-17
07613327519372AXS VECTA 46Stryker CorporationQJP2021-12-17
07613327519389AXS VECTA 46Stryker CorporationNRY2021-12-17
00763000425272Solitaire ™ PlatinumMicro Therapeutics, Inc.NRY2021-03-12
00763000425333Solitaire ™ PlatinumMicro Therapeutics, Inc.NRY2021-03-12
00763000425395Solitaire ™ PlatinumMicro Therapeutics, Inc.NRY2021-03-12
00763000425456Solitaire ™ PlatinumMicro Therapeutics, Inc.NRY2021-03-12
07613327299946Trevo NXTStryker CorporationNRY2020-04-20
07613327313956Trevo Trak 21Stryker CorporationQJP2020-04-17
00763000270179Solitaire™ X-PACKMicro Therapeutics, Inc.NRY2019-11-08
00763000270193Solitaire™ X-PACKMicro Therapeutics, Inc.NRY2019-11-08
00763000270353Solitaire™ X-PACKMicro Therapeutics, Inc.NRY2019-11-08
00763000270353Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-08
00763000270377Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-08
00763000270377Solitaire™ X-PACKMicro Therapeutics, Inc.NRY2019-11-08
00763000270537Solitaire™ X-PACKMicro Therapeutics, Inc.NRY2019-11-08
00763000270537Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-08