AXS Catalyst Distal Access Catheter 058x115cm, AXS Catalyst Distal Access Catheter 058x132cm, AXS Catalyst Distal Access Catheter 060x132cm

Q: Who is the manufacturer of AXS Catalyst Distal Access Catheter 058x115cm, AXS Catalyst Distal Access Catheter 058x132cm, AXS Catalyst Distal Access Catheter 060x132cm?

Stryker filed the 510(k) submission for AXS Catalyst Distal Access Catheter 058x115cm, AXS Catalyst Distal Access Catheter 058x132cm, AXS Catalyst Distal Access Catheter 060x132cm (K151667).

Q: What is the FDA product code for AXS Catalyst Distal Access Catheter 058x115cm, AXS Catalyst Distal Access Catheter 058x132cm, AXS Catalyst Distal Access Catheter 060x132cm?

DQY. It is classified under 21 CFR 870.1250 as a Class 2 device in the Cardiovascular panel.

Q: What is the regulatory pathway for AXS Catalyst Distal Access Catheter 058x115cm, AXS Catalyst Distal Access Catheter 058x132cm, AXS Catalyst Distal Access Catheter 060x132cm?

510(k) clearance (submission type: Traditional).

Q: What are the predicate devices for AXS Catalyst Distal Access Catheter 058x115cm, AXS Catalyst Distal Access Catheter 058x132cm, AXS Catalyst Distal Access Catheter 060x132cm?

Concentric HD Guide Catheter (K090335); Modified HD Guide Catheter (K110483); Modified HD Guide Catheter (K133177).

Q: Who can help prepare an FDA 510(k) submission like AXS Catalyst Distal Access Catheter 058x115cm, AXS Catalyst Distal Access Catheter 058x132cm, AXS Catalyst Distal Access Catheter 060x132cm?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

K151667 · Stryker · DQY · Nov 13, 2015 · Cardiovascular

Device Facts

Record ID	K151667
Device Name	AXS Catalyst Distal Access Catheter 058x115cm, AXS Catalyst Distal Access Catheter 058x132cm, AXS Catalyst Distal Access Catheter 060x132cm
Applicant	Stryker
Product Code	DQY · Cardiovascular
Decision Date	Nov 13, 2015
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.1250
Device Class	Class 2

Intended Use

The AXS Catalyst Distal Access Catheter is indicated for use in facilitating the insertion and guidance of appropriately sized interventional devices into a selected blood vessel in the peripheral and neurovascular systems. The AXS Catalyst Distal Access Catheter is also indicated for use as a conduit for retrieval devices.

Device Story

AXS Catalyst Distal Access Catheter is a sterile, single-lumen, variable-stiffness catheter; used in peripheral and neurovascular systems. Device facilitates insertion/guidance of interventional devices; serves as conduit for retrieval devices. Features hydrophilic coating for friction reduction; radiopaque marker for angiographic visualization; luer hub for flushing/aspiration. Packaged with Rotating Hemostatic Valve (RHV), Tuohy Borst valve, and peel-away introducer sheaths. Operated by clinicians in clinical settings. Provides conduit for interventional tools; aids in navigation of tortuous vasculature; supports aspiration/flushing. Benefits include improved access to target vessels and support for retrieval procedures.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing (dimensional verification, tip buckling, lubricity/durability, trackability, tensile strength, leak resistance, torsional bond strength, flexural fatigue, kink radius, patency) and acute animal model evaluation.

Technological Characteristics

Single-lumen, variable-stiffness catheter. Materials: Pebax/Nylon outer jacket, PTFE inner layer, stainless steel/Nitinol/polymer fiber reinforcement, thermoplastic rubber strain relief, platinum/iridium marker band, cyanoacrylate adhesive. Hydrophilic coating. Sterilization: 100% Ethylene Oxide. Dimensions: 5.3F-6.0F OD, 115-132 cm length. Standalone device.

Indications for Use

Indicated for facilitating insertion and guidance of interventional devices into peripheral and neurovascular blood vessels; also indicated as a conduit for retrieval devices. No specific patient population or contraindications provided.

Regulatory Classification

Identification

A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.

Predicate Devices

Concentric HD Guide Catheter (K090335)
Modified HD Guide Catheter (K110483)
Modified HD Guide Catheter (K133177)

Related Devices

K183463 — AXS Catalyst Distal Access Catheter 068 x 115cm, AXS Catalyst Distal Access Catheter 068 x 125cm, AXS Catalyst Distal Access Catheter 068 x 132cm · Stryker · Mar 13, 2019
K233205 — Distal Access Catheter · Shanghai Heartcare Medical Technology Co., Ltd. · Dec 22, 2023
K253032 — AXS Lift Intracranial Base Catheter · Stryker Neurovascular · Feb 11, 2026
K243593 — AXS Lift Intracranial Base Catheter · Stryker Neurovascular · Feb 18, 2025
K200206 — AXS Vecta 71 Intermediate Catheter, AXS Vecta 74 Intermediate Catheter · Stryker Neurovascular · Feb 27, 2020

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other, with flowing lines representing hair or movement. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 November 13, 2015 Stryker Neurovascular Ms. Rhoda M. Santos Principal Regulatory Affairs Specialist 47900 Bayside Parkway Fremont, California 94538 Re: K151667 Trade/Device Name: AXS Catalyst™ Distal Access Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: October 9, 2015 Received: October 13, 2015 Dear Ms. Santos: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices. good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {1}------------------------------------------------ If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, Carlos L. Pena -S Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K151667 #### Device Name AXS Catalyst™ Distal Access Catheter #### Indications for Use (Describe) The AXS Catalyst Distal Access Catheter is indicated for use in facilitating the insertion and guidance of appropriately sized interventional devices into a selected blood vessel in the peripheral and neurovascular systems. The AXS Catalyst Distal Access Catheter is also indicated for use as a conduit for retrieval devices. Type of Use (Select one or both, as applicable) | Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | <div> <object data="checkbox_checked.svg" height="20" type="image/svg+xml" width="20"> <img alt="Checked" height="20" src="checkbox_checked.png" width="20"/> </object> </div> | <div> <object data="checkbox_unchecked.svg" height="20" type="image/svg+xml" width="20"> <img alt="Unchecked" height="20" src="checkbox_unchecked.png" width="20"/> </object> </div> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ | 510(k) Summary | | | |------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|------------------------------| | Date Prepared: | July 27, 2015 | | | Trade Name: | AXS Catalyst™ Distal Access Catheter | | | Common Name: | Percutaneous Catheter | | | Classification Name: | Percutaneous Catheter, 21CFR 870.1250 – Class II | | | Product Code: | DQY | | | Submitter: | Stryker Neurovascular 47900 Bayside Parkway Fremont, CA 94538-6515 (FDA Registration Number: 3008853977) | | | Contact: | Rhoda M. Santos Principal Regulatory Affairs Specialist Phone: 510-413-2269 Fax: 510-413-2588 Email: rhoda.santos@stryker.com | | | Legally Marketed Predicate Device(s): | Reference (Clearance Date) | Device | | | K090335 (May 6, 2009) | Concentric HD Guide Catheter | | | K110483 (April 4, 2011) | Modified HD Guide Catheter | | | K133177 (February 25, 2014) | Modified HD Guide Catheter | ## Device Description The AXS Catalyst™ Distal Access Catheter is a sterile, single lumen, variable stiffness catheter designed for use in facilitating the insertion and guidance of appropriately sized interventional devices into the peripheral and neuro vascular system. The catheter shaft has a hydrophilic coating to reduce friction during use. The catheter includes a radiopaque marker on the distal end for angiographic visualization and a luer hub on the proximal end allowing attachments for flushing and aspiration. It is packaged with a Rotating Hemostastic Valve (RHV) and Tuohy Borst valve with sideport for flushing, insertion of catheters and aspiration. The peel away introducer sheaths are designed to protect the distal tip of the catheter during insertion into the RHV or Tuohy Borst. {4}------------------------------------------------ ## Indications for Use The AXS Catalyst Distal Access Catheter is indicated for use in facilitating the insertion and guidance of appropriately sized interventional devices into a selected blood vessel in the peripheral and neurovascular systems. The AXS Catalyst Distal Access Catheter is also indicated for use as a conduit for retrieval devices. ## Technological Characteristics and Product Feature Comparison Stryker Neurovascular believes the AXS Catalyst Distal Access Catheters are substantially equivalent to the predicate devices (K133177, K110483, K090335) based on similar intended use / indications for use, same or similar materials, same fundamental design, and the same fundamental operating principles. A comparison of the subject device with the predicate device is summarized in the table below. | Feature | Reference Predicate Device HD Guide Catheter (DAC®) (K090335) | Reference Predicate Device Modified HD Guide Catheter (DAC®) (K110483) | Primary Predicate Device Modified HD Guide Catheter (DAC®) (K133177) | Subject Device AXS Catalyst Distal Access Catheter | Rationale for difference (if applicable) | |--------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use / Indications for Use | Indicated for use in facilitating the insertion and guidance of an occlusion catheter, infusion catheter or other appropriate microcatheter into a selected blood vessel in the peripheral, coronary or neuro vascular systems. It may also be used as a diagnostic angiographic catheter. | Same | The Modified HD Guide Catheter is indicated for use in facilitating the insertion and guidance of an occlusion catheter, infusion catheter or other appropriate microcatheter into a selected blood vessel in the peripheral, coronary and neuro vascular systems. It may also be used as a diagnostic angiographic catheter and as a conduit for retrieval devices. | The AXS Catalyst Distal Access Catheter is indicated for use in facilitating the insertion and guidance of appropriately sized interventional devices into a selected blood vessel in the peripheral and neurovascular systems. The AXS Catalyst Distal Access Catheter is also indicated for use as a conduit for retrieval devices. | Intended Use / Indications for Use reflect user preferences. AXS Catalyst Catheter is not intended to be marketed for use in coronary systems nor is it intended to be used as a diagnostic catheter. Bench testing and animal testing has demonstrated that the proposed intended use / indications for use do not affect the safety and effectiveness of the device. | | Device Description | The HD Guide Catheter is a single- lumen, braided shaft, variable | Same | The Modified HD Guide Catheter is a single-lumen, braided shaft, | The AXS Catalyst™ Distal Access Catheter is a single lumen, variable | Additional accessories included for ease of use | | Feature | Reference Predicate Device HD Guide Catheter (DAC®) (K090335) | Reference Predicate Device Modified HD Guide Catheter (DAC®) (K110483) | Primary Predicate Device Modified HD Guide Catheter (DAC®) (K133177) | Subject Device AXS Catalyst Distal Access Catheter | Rationale for difference (if applicable) | | | stiffness catheter with a radiopaque marker on the distal end and a luer hub on the proximal end. The catheter shaft has a hydrophilic coating to reduce friction during use. A rotation hemostatic side arm adapter is provided with each catheter. | | variable stiffness catheter with radiopaque marker on the distal end and a luer hub on the proximal end. The catheter shaft has a hydrophilic coating to reduce friction during use. Device dimensions and configuration are shown on the product label. A rotating hemostasis valve with side-arm adapter is provided with each catheter. The rotating hemostasis valve is typically "y" shaped with a female luer lock and a manual hemostasis valve. The female port allows for aspiration and contrast injections while the hemostasis valve allows direct arterial access when using other devices such as guidewires and/or interventional devices. | stiffness catheter designed for use in facilitating the insertion and guidance of appropriately sized interventional devices into the peripheral and neuro vascular system. The catheter shaft has a hydrophilic coating to reduce friction during use. The catheter includes a radiopaque marker on the distal end for angiographic visualization and a luer hub on the proximal end allowing attachments for flushing and aspiration. It is packaged with a Rotating Hemostastic Valve (RHV) and Tuohy Borst valve with sideport for flushing, insertion of catheters and aspiration. The peel away introducer sheaths are designed to protect the distal tip of the catheter during insertion into the RHV or Tuohy Borst. | Bench testing and animal testing has demonstrated that the proposed intended use / indications for use do not affect the | | Feature | Reference Predicate Device HD Guide Catheter (DAC®) (K090335) | Reference Predicate Device Modified HD Guide Catheter (DAC®) (K110483) | Primary Predicate Device Modified HD Guide Catheter (DAC®) (K133177) | Subject Device AXS Catalyst Distal Access Catheter | Rationale for difference (if applicable) | | Accessory Devices Provided (not in direct contact with patient) | RHV | Same | Same | RHV Tuohy Borst Valve with Sideport (2) Peel Away Sheaths | Additional accessories included for ease of use. Bench testing and animal testing has demonstrated that the additional accessories do not affect the safety and effectiveness of the device. | | Regulation Number | 21CFR 870.1250 | Same | Same | Same | NA | | Regulation Name | Percutaneous Catheter | Same | Same | Same | NA | | Regulatory Class | II | Same | Same | Same | NA | | Product Code | DQY, DQO | Same | Same | DQY | Product code reflects intended use / indications for use | | Materials | | | | | | | Outer Jacket | Pebax | Same | Same | Same with Nylon | Nylon material added to meet performance needs of user. Bench testing and animal testing has demonstrated that the additional nylon material does not affect the safety and effectiveness of the device. | | Feature | Reference Predicate Device HD Guide Catheter (DAC®) (K090335) | Reference Predicate Device Modified HD Guide Catheter (DAC®) (K110483) | Primary Predicate Device Modified HD Guide Catheter (DAC®) (K133177) | Subject Device AXS Catalyst Distal Access Catheter | Rationale for difference (if applicable) | | Reinforcement | Stainless Steel | Same | Same | Same with Nitinol and Polymer fiber | Nitinol wire and polymer fiber added to meet performance needs of user. Bench testing and animal testing has demonstrated that the additional nitinol and polymer fiber materials do not affect the safety and effectiveness of the device. | | Strain Relief | Polyolefin | Same | Same | Thermoplastic rubber | Use of thermoplastic rubber material is consistent with other commercially available Stryker Neurovascular products. Bench testing has demonstrated that the thermoplastic rubber material does not affect the safety and effectiveness of the device. | | Inner layer | PTFE | Same | Same | Same | NA | | Catheter Hub | Pebax | Same | Same | Nylon | Use of nylon material is consistent with other commercially available Stryker Neurovascular products. Bench testing has demonstrated that the nylon material does not affect the safety and effectiveness of the device. | | Feature | Reference Predicate Device HD Guide Catheter (DAC®) (K090335) | Reference Predicate Device Modified HD Guide Catheter (DAC®) (K110483) | Primary Predicate Device Modified HD Guide Catheter (DAC®) (K133177) | Subject Device AXS Catalyst Distal Access Catheter | Rationale for difference (if applicable) | | Marker Band | Platinum/Iridium | Same | Same | Same | NA | | Adhesive | Acrylic (Acrylated Urethane) | Same | Same | Cyanoacrylate | Use of cyanoacrylate adhesive is consistent with other commercially available Stryker Neurovascular products. Bench testing has demonstrated that the cyanoacrylate adhesive does not affect the safety and effectiveness of the device. | | Outer jacket coating | hydrophilic coating | Same | Same | Same | NA | | Labeled Shaft Outer Diameter | OD of effective length: 3.9F, 5.2F | OD of effective length: 6.3F | Same as predicate devices, K090335 and K114083 | Distal OD: 5.3F, 5.4F Proximal OD: 5.6F, 6.0F | NA | | Effective Lengths | 115 cm, 125 cm, 136 cm | 105 cm, 120 cm | Same as predicate devices, K090335 and K114083 | 115 cm, 132 cm | NA | | Packaging Materials and Configuration | Polyethylene Tube and HDPE Packaging Card | Same | Same | Same | NA | | Sterilization Method | EO Sterilization | Same | Same | Same | NA | | How Supplied | Pebax | Same | Same…