FDA.reportPublic FDA data

AXS INFINITY LS PLUS

Primary DI
07613327459197
Brand
AXS INFINITY LS PLUS
Company
Stryker Corporation
Model
INC-11196-80
Catalog number
INC-11196-80
Device description
Long Sheath
Published
2018-10-08
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
DTLAdaptor, stopcock, manifold, fitting, cardiopulmonary bypass
GCCDilator, catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQYCatheter, PercutaneousCardiovascular2
DTLAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary BypassCardiovascular2
GCCDilator, CatheterGeneral, Plastic Surgery1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K172468000
K193034000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172468000091 Long Sheath, 70 cm, 091 Long Sheath, 80 cm, 091 Long Sheath, 90 cmInneuroco, Inc.2017-12-06DQY
K193034000AXS Infinity LS Plus Long SheathStryker Neurovascular2019-11-29DQY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613327459197PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327459197076133274591977613327459197

GMDN Terms#

Term, Definition table
TermDefinition
Vascular guide-catheter, single-useA sterile, flexible tube intended to be used for the percutaneous transluminal passage and placement of a diagnostic/interventional catheter, lead (e.g., pacing lead, balloon dilatation catheter), or guidewire through its lumen(s), within the vascular system. It may be rigid or flexible, non-steerable or steerable, single or multiple lumen(s), and the distal section of the tube can have a variety of preformed shapes (e.g., straight, hockey stick). It is not intended for infusion, is not a microcatheter (i.e., not intended to access superselective small vessels), and does not include a transseptal needle. It may include a disposable percutaneous introduction set. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length80Centimeter
Lumen/Inner Diameter0.091Inch

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
07613327631388N/A50275000005027-500-0002026-06-16
07613327631395N/A50275001005027-500-1002026-06-19
07613327632774N/A50275004005027-500-4002026-06-16
07613327651119VersiQuad0234112012234-112-0122026-07-16
07613327651126VersiQuad0234112611234-112-6112026-07-16
07613327651133VersiQuad0234112100234-112-1002026-07-16
07613327651140VersiQuad0234112608234-112-6082026-07-16
07613327651157VersiQuad0234112109234-112-1092026-07-16
07613327651164VersiQuad0234112500234-112-5002026-07-16
07613327651171VersiQuad0234112108234-112-1082026-07-16
07613327651195VersiQuad0234112607234-112-6072026-07-16
07613327651201VersiQuad0234112110234-112-1102026-07-16
07613327651218VersiQuad0234112609234-112-6092026-07-16
07613327651225VersiQuad0234112610234-112-6102026-07-16
07613327507935Stroke Fast PackSFP913140SFP9131402020-06-30
07613327507942Stroke Fast PackSFP913150SFP9131502020-06-30
07613327507959Stroke Fast PackSFP913160SFP9131602020-06-30
07613327507966Stroke Fast PackSFP913170SFP9131702020-06-30
07613327507973Stroke Fast PackSFP913180SFP9131802020-06-30
07613327507980Stroke Fast PackSFP913190SFP9131902020-06-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00810024671892CPS Locator 3D, Medium Delivery CatheterCENTERPOINT SYSTEMS LLCDQY2026-07-13
00810024671908CPS Locator 3D, Large Delivery CatheterCENTERPOINT SYSTEMS LLCDQY2026-07-13
00810024671915CPS Locator 3D, Medium, Extra Long Delivery CatheterCENTERPOINT SYSTEMS LLCDQY2026-07-13
00810024671922CPS Locator 3D, Large, Extra Long Delivery CatheterCENTERPOINT SYSTEMS LLCDQY2026-07-13
008537990079308F Base Camp System 2.0 90cmROUTE 92 MEDICALDQY2026-07-08
10801902218732ARROWTELEFLEX INCORPORATEDDQY2026-06-24
00810024671953SSPC NXT Delivery CatheterCENTERPOINT SYSTEMS LLCDQY2026-06-01
08718481740330Guidion ShortIMDS Operations B.V.DQY2026-06-01
08718481740347FlowGuideIMDS Operations B.V.DQY2026-06-01
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00810212933559SURGIPROSSurgipros, LLCGCC2026-05-28
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