FDA.reportPublic FDA data

AXS VECTA 71

Primary DI
07613327459234
Brand
AXS VECTA 71
Company
Stryker Corporation
Model
INC-11129-132
Catalog number
INC-11129-132
Device description
Intermediate Catheter
Published
2018-10-26
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
DQYCatheter, percutaneous
DTLAdaptor, stopcock, manifold, fitting, cardiopulmonary bypass
DYBIntroducer, catheter
NRYCATHETER, THROMBUS RETRIEVER
QJPCatheter, Percutaneous, Neurovasculature

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQYCatheter, PercutaneousCardiovascular2
DTLAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary BypassCardiovascular2
DYBIntroducer, CatheterCardiovascular2
NRYCatheter, Thrombus RetrieverCardiovascular2
QJPCatheter, Percutaneous, NeurovasculatureCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K172167000
K190212000
K190833000
K191768000
K200206000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172167000Zenith Flex SystemInneuroco, Inc.2018-04-19NRY
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
07613327459234PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327459234076133274592347613327459234

GMDN Terms#

Term, Definition table
TermDefinition
Thrombectomy suction catheterA flexible or semi-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/stented blood vessels, native/synthetic bypass grafts, and/or haemodialysis access grafts, through suction (aspiration) in conjunction with a syringe or dedicated suction pump system (pump not included). It may additionally be intended for infusion of fluids and/or used as a guide-catheter to facilitate introduction of a thrombectomy wire-net (not included) to remove residual thrombus. Collection containers may be included with the catheter. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length0
Lumen/Inner Diameter0

Storage And Handling#

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

Contacts#

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

Regulatory Flags#

DUNS number
042405446
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
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00850024195134MOLLIMS-00009MM10122022-06-27
00850024195219MOLLIMP2015A2024-04-13
00850024195141MOLLIMP20012023-03-30
00850024195158MOLLIMT20012023-03-30
00850024195004MOLLIMP10012021-08-27
00850024195011MOLLIMT10012021-08-27
07613327651232SportSuite0203-10000203-10002026-08-21
07613327679410Mini-PRO Pediatric Restraint System (with Modified X-Restraints)6410055500016410055500012026-08-21
07613327170559VertaPlex HV04066220150406-622-0152016-09-23
07613327358308iVAS8080108000808-010-8002019-01-11
04546540434371PCD SpinePlex05055820000505-582-0002015-09-24
04546540434388PCD SpinePlex05055830000505-583-0002015-09-24
04546540434395PCD SpinePlex05055850000505-585-0002015-09-24
04546540434401PCD SpinePlex05055860000505-586-0002015-09-24
04546540434418PCD05055870000505-587-0002015-09-24
04546540434425PCD05055890000505-589-0002015-09-24
07613327639032Broadway SystemBRW8E100D-3PK01BRW8E100D-3PK012025-03-12
07613327639049Broadway SystemBRW8E105D-3PK01BRW8E105D-3PK012025-03-12
07613327623338AXS LiftLIFT074095-01LIFT074095-012025-03-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10801902227246ARROWTELEFLEX INCORPORATEDDYB2026-08-27
10884450119836Prelude EASE™Merit Medical Systems, Inc.DYB2026-08-27
05391539370296Millipede88 CatheterPERFUZE LIMITEDNRY2026-08-21
00884450838211Prelude Roadster™Merit Medical Systems, Inc.DYB2026-08-18
00843152100057IOPS Visionary SystemCenterline Biomedical, Inc.DQY2026-02-24
08718122013984Primum Guiding CatheterPendraCare International B.V.DQY2026-02-02
08718122028896Primum Guiding CatheterPendraCare International B.V.DQY2026-02-02
08718122013915Primum Guiding CatheterPendraCare International B.V.DQY2026-02-02
00812212030764Zoom 4S CatheterIMPERATIVE CARE, INC.QJP2025-11-24
00812212030764Zoom 4S CatheterIMPERATIVE CARE, INC.NRY2025-11-24
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00812212030771Zoom 4S CatheterIMPERATIVE CARE, INC.NRY2025-11-24
00812212030788Zoom 4S CatheterIMPERATIVE CARE, INC.QJP2025-11-24
00812212030788Zoom 4S CatheterIMPERATIVE CARE, INC.NRY2025-11-24
10841156111250GUIDELINERTELEFLEX INCORPORATEDDQY2025-07-14
10801902217773ARROWTELEFLEX INCORPORATEDDQY2024-04-08
10801902217988ARROWTELEFLEX INCORPORATEDDQY2024-03-18
10801902215502ARROWTELEFLEX INCORPORATEDDQY2023-07-10
10801902215267ARROWTELEFLEX INCORPORATEDDQY2023-07-07
10801902215281ARROWTELEFLEX INCORPORATEDDQY2023-06-27
10801902215526ARROWTELEFLEX INCORPORATEDDQY2023-06-19
10801902215229ARROWTELEFLEX INCORPORATEDDQY2023-06-05
00850291007321Artix BGInari Medical, Inc.DQY2023-05-09
00850291007260Intri24 Introducer SheathInari Medical, Inc.DYB2023-03-20
10801902180589ARROWTELEFLEX INCORPORATEDDQY2022-11-29
10801902182187ARROWTELEFLEX INCORPORATEDDQY2022-11-29
10801902183528ARROWTELEFLEX INCORPORATEDDQY2022-11-29