FDA.reportPublic FDA data

AXS VECTA 46

Primary DI
07613327519358
Brand
AXS VECTA 46
Company
Stryker Corporation
Model
INC-11814-125
Catalog number
INC-11814-125
Device description
Intermediate Catheter
Published
2021-12-17
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
NRYCATHETER, THROMBUS RETRIEVER
QJPCatheter, Percutaneous, Neurovasculature

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K190338000
K202752000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190338000046 Zenith FlexInneuroco, Inc.2019-08-02NRY
K202752000AXS Vecta 46 Intermediate CatheterStryker Neurovascular2021-08-27QJP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613327519358PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327519358076133275193587613327519358

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
Length125Centimeter
Lumen/Inner Diameter0.046Inch

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
07613327625172Steri-Shield04248010000424-801-0002025-02-21
07613327625257Steri-Shield04247212000424-721-2002025-02-21
07613327625288Steri-Shield04247412000424-741-2002025-02-21
07613327625295Steri-Shield04248211000424-821-1002025-02-21
07613327625332Steri-Shield04248212000424-821-2002025-02-21
07613327625349Steri-Shield04248312000424-831-2002025-02-21
07613327625363Steri-Shield04248512000424-851-2002025-02-21
07613327625370Steri-Shield04249210000424-921-0002025-02-21
07613327625387Steri-Shield04249410000424-941-0002025-02-21
07613327625394Steri-Shield04249510000424-951-0002025-02-21
07613327625400Steri-Shield04249310000424-931-0002025-02-21
07613327625417Steri-Shield04249412000424-941-2002025-02-21
07613327625424Steri-Shield04249311000424-931-1002025-02-21
07613327625431Steri-Shield04249211000424-921-1002025-02-21
07613327625448Steri-Shield04249312000424-931-2002025-02-21
07613327625455Steri-Shield04249512000424-951-2002025-02-21
07613327625462Steri-Shield04249212000424-921-2002025-02-21
07613327625479Steri-Shield04249511000424-951-1002025-02-21
07613327625486Steri-Shield04249411000424-941-1002025-02-21
07613327465655Neptune0703-046-0060703-046-0062019-10-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850074235132Toro 88 Superbore CatheterToro Neurovascular, Inc.QJP2026-07-31
008537990079308F Base Camp System 2.0 90cmROUTE 92 MEDICALQJP2026-07-08
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
00763000974077Riptide™Micro Therapeutics, Inc.NRY2026-03-30
10886704088097CEREGLIDECerenovus, Inc.QJP2025-10-13
10886704088097CEREGLIDECerenovus, Inc.NRY2025-10-13
10886704088103CEREGLIDECerenovus, Inc.QJP2025-10-13
10886704088103CEREGLIDECerenovus, Inc.NRY2025-10-13
10886704088110CEREGLIDECerenovus, Inc.NRY2025-10-13
10886704088110CEREGLIDECerenovus, Inc.QJP2025-10-13
10886704088141CEREGLIDECerenovus, Inc.NRY2025-10-13
10886704088141CEREGLIDECerenovus, Inc.QJP2025-10-13
10886704086437CEREGLIDECerenovus, Inc.QJP2025-09-26
10886704086451CEREGLIDECerenovus, Inc.QJP2025-09-26
10886704086475CEREGLIDECerenovus, Inc.QJP2025-09-26
10886704086499CEREGLIDECerenovus, Inc.QJP2025-09-26
10886704086512CEREGLIDECerenovus, Inc.NRY2025-09-26
10886704086536CEREGLIDECerenovus, Inc.QJP2025-09-26
10886704086550CEREGLIDECerenovus, Inc.QJP2025-09-26
10886704086598CEREGLIDECerenovus, Inc.QJP2025-09-26
10886704086611CEREGLIDECerenovus, Inc.QJP2025-09-26
10886704088073CEREGLIDECerenovus, Inc.QJP2025-09-26
07613327623352AXS LiftStryker CorporationQJP2025-03-04
07613327623390AXS LiftStryker CorporationQJP2025-03-04
008537990077258F Base Camp system 2.0 90cmROUTE 92 MEDICALQJP2024-10-14
00810068561944Carrier™ Delivery CatheterBALT USA LLCQJP2023-11-07