AXS VECTA 71

Basic Information

• Brand Name: AXS VECTA 71
• Primary DI: 07613327459227
• Version / Model: INC-11129-125
• Catalog Number: INC-11129-125
• Company Name: Stryker Corporation
• Labeler DUNS: 042405446
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-10-26
• Public Version: 6
• Public Version Date: 2022-11-09
• Public Version Status: Update
• Public Device Record Key: e995c4d2-525d-414c-b0c5-479972328ab2

Device Description

Intermediate Catheter

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DQY	Catheter, percutaneous	Cardiovascular	870.1250	2
NRY	CATHETER, THROMBUS RETRIEVER	Cardiovascular	870.1250	2
QJP	Catheter, Percutaneous, Neurovasculature	Cardiovascular	870.1250	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58173	Thrombectomy suction catheter	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07613327459227	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K172167	000
K190212	000
K190833	000
K191768	000
K200206	000

Device Sizes

Type	Value	Unit	Text
Length	125.0	Centimeter
Lumen/Inner Diameter	0.071	Inch

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store in cool, dry, dark place.