Who is the manufacturer of AXS Vecta 46 Intermediate Catheter?

Stryker Neurovascular filed the 510(k) submission for AXS Vecta 46 Intermediate Catheter (K202752).

What is the FDA product code for AXS Vecta 46 Intermediate Catheter?

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

What is the regulatory pathway for AXS Vecta 46 Intermediate Catheter?

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

What are the predicate devices for AXS Vecta 46 Intermediate Catheter?

AXS Vecta Intermediate Catheter (K190833).

Who can help prepare an FDA 510(k) submission like AXS Vecta 46 Intermediate Catheter?

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.

AXS Vecta 46 Intermediate Catheter

K202752 · Stryker Neurovascular · QJP · Aug 27, 2021 · Cardiovascular

Device Facts

Record ID	K202752
Device Name	AXS Vecta 46 Intermediate Catheter
Applicant	Stryker Neurovascular
Product Code	QJP · Cardiovascular
Decision Date	Aug 27, 2021
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.1250
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The AXS Vecta Intermediate Catheter is indicated for use in facilitating the insertion and guidance of appropriately sized interventional devices into a selected blood vessel in the neurovascular system. The AXS Vecta Intermediate Catheter is also indicated for use as a conduit for retrieval devices.

Device Story

Single-lumen, flexible, variable-stiffness catheter; used in neurovascular system. Advanced into vasculature by trained physician under fluoroscopic guidance using compatible sheath/guide catheter and microcatheter/guidewire. Features radiopaque marker band for visualization and hydrophilic coating to reduce friction. Acts as conduit for interventional or retrieval devices. Facilitates endovascular procedures; assists in navigating tortuous neurovasculature. Benefits patient by enabling access to target sites for neurointerventional therapy.

Clinical Evidence

No clinical data. Bench testing only. Simulated use testing in tortuous in vitro models (ICA/MCA) confirmed performance. Burst testing and particulate testing verified design integrity.

Technological Characteristics

Single-lumen, variable-stiffness catheter. Materials: polymeric outer jacket, nitinol reinforcement, PTFE inner layer, polyolefin strain relief, polycarbonate hub, platinum/iridium marker band, cyanoacrylate adhesive. Hydrophilic coating. EO sterilized. ISO 10555-1 compliant. No software.

Indications for Use

Indicated for facilitating insertion/guidance of interventional devices into neurovascular blood vessels and as a conduit for retrieval devices in patients requiring neurointerventional procedures.

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

AXS Vecta Intermediate Catheter (K190833)

Reference Devices

Zenith Flex Aspiration System (046 Zenith Flex Catheter) (K190338)

Related Devices

K190833 — AXS Vecta Aspiration Catheter · Stryker Neurovascular · Dec 15, 2019
K241244 — CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate Catheter · Cerenovus, Inc. · Oct 16, 2024
K191237 — CERENOVUS Large Bore Catheter · Codman & Shurtleff, Inc. · Nov 8, 2019
K182512 — Route 92 Medical Delivery Catheter · Route 92 Medical, Inc. · Dec 10, 2018
K251014 — APRO 45 Catheter · Alembic, LLC · May 1, 2025

Submission Summary (Full Text)

{0}------------------------------------------------ August 27, 2021 Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. Stryker Neurovascular Shivani Patel Senior Staff Regulatory Affairs Specialist 47900 Bayside Parkway Fremont, California 94538 ## Re: K202752 Trade/Device Name: AXS Vecta 46 Intermediate Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: OJP Dated: July 23, 2021 Received: July 26, 2021 ## Dear Shivani Patel: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 {1}------------------------------------------------ 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, # Xiaolin Zheng -S Xiaolin Zheng, Ph.D. Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K202752 Device Name AXS Vecta 46 Intermediate Catheter #### Indications for Use (Describe) The AXS Vecta Intermediate Catheter is indicated for use in facilitating the insertion and guidance of appropriately sized interventional devices into a selected blood vessel in the neurovascular system. The AXS Vecta Internediate Catheter is also indicated for use as a conduit for retrieval devices. | Type of Use (Select one or both, as applicable) | | |----------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------| | <div> ✓ Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </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 K202752 ## Introduction: According to the requirements of 21 CFR 807.92, the following information provides sufficient details to understand the basis for a determination of substantial equivalence. ## Submitter Name, Address, and Content: | Submitter: | Stryker Neurovascular 47900 Bayside Parkway Fremont, CA 94538-6515 (FDA Registration Number: 3008853977) | |---------------------------------|-------------------------------------------------------------------------------------------------------------------------| | Contact: | Shivani Patel Senior Staff Regulatory Affairs Specialist Phone: 341-465-2199 Email: shivani.patel2@stryker.com | | Date Prepared: | August 24, 2021 | | Device Name and Classification: | Trade/Proprietary Name: AXS Vecta® 46 Intermediate Catheter | | Common Name: | Percutaneous Catheter | | Classification Name: | Percutaneous Catheter, 21CFR 870.1250 – Class II | | Product Code: | QJP | {4}------------------------------------------------ | Legally Marketed Predicate Devices: | Predicate Devices | Reference Device | | |------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | AXS Vecta Intermediate Catheter (K190833) | Zenith Flex Aspiration System (046 Zenith Flex Catheter) (K190338) | | | Detail | Submission Subject Device | Predicate Device | Reference Device | | Manufacturer | Stryker Neurovascular | Stryker Neurovascular | Stryker Neurovascular | | 510(k) Number | K202752 | K190833 | K190338 | | Device Trade Name | AXS Vecta 46 Intermediate Catheter | AXS Vecta Intermediate Catheter | Zenith Flex Aspiration System (046 Zenith Flex Catheter) | | Regulation Number | 21 CFR 870.1250 | Same | Same | | Regulation Name | Percutaneous Catheter | Same | Same | | Classification | II | Same | Same | | Product Code | QJP | DQY | NRY | | Intended Use/Indication for Use | The AXS Vecta Intermediate Catheter is indicated for use in facilitating the insertion and guidance of appropriately sized interventional devices into a selected blood vessel in the neurovascular system. The AXS Vecta Intermediate Catheter is also indicated for use as a conduit for retrieval devices. | The AXS Vecta Intermediate 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 Vecta Intermediate Catheter is also indicated for use as a conduit for retrieval devices. | The Zenith Flex Aspiration System, including the 046 Zenith Flex Aspiration Catheter, Aspiration Tubing Set, and VC-701 Cliq Aspirator Pump, is indicated in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral – M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who failed IV t-PA therapy are candidates for treatment. | | Device Description | The AXS Vecta 46 Intermediate Catheter is advanced into the | The AXS Vecta Intermediate Catheter is advanced into the | The InNeuroCo 046 Zenith Flex Catheter is a variable stiffness catheter | | | neurovasculature by a physician trained in interventional endovascular procedures using a compatible sheath or guide catheter, and over an appropriately sized microcatheter or guide wire. One peel- away introduce sheath is provided in the package to provide support and facilitate the introduction of the AXS Vecta 46 Intermediate Catheter tip into the sheath/guide catheter valve. Once the assembly is inserted, the peel-away introducer sheath can be removed. Under fluoroscopic guidance, the assembly can be advanced through the vasculature to the desired location. | neurovasculature by a physician trained in interventional endovascular procedures using a compatible sheath or guide catheter, and over an appropriately sized microcatheter, guide wire, and/or the Scout Introducer. Two peel- away introducer sheaths are provided in the package to provide support and facilitate the introduction of the AXS Vecta Intermediate Catheter tip into the sheath/guide catheter valve. Once the assembly is inserted, the peel-away introducer sheath can be removed. Under fluoroscopic guidance, the assembly can be advanced through the vasculature to the desired location. | that has a catheter shaft reinforced with Nitinol to provide support. The proximal section has an embedded nitinol flat wire cross coil that transitions to a nitinol round wire single coil in the distal end. It has a radiopaque Platinum/Iridium marker band on the distal end. The 046 Zenith Flex Catheter is available with an internal diameter of 0.046 inches. The outer diameter is 0.058 inches along the proximal shaft and 0.056 inches at the distal tip. The 046 Zenith Flex Catheter is available in two working lengths: 153 cm, and 160 cm. The 046 Zenith Flex Catheter has a PTFE-lined lumen to reduce friction as it travels over a guidewire. Accessories included with the device are a Tuohy-Borst Hemostasis Valve and peel-away introducer. | | Accessory Devices Provided (not in direct contact with patient) | Hemostasis Valve, 1 Peel-Away Introducer | Hemostasis Valve, 2 Peel-Away Introducers, Scout Introducer | Same as Subject device | | Outer Jacket | Polymeric catheter | Same | Same | | Reinforcement | Nitinol | Stainless Steel/Nitinol | Same as Subject device | | Strain Relief | Polyolefin | Same | Same | | Inner Layer | PTFE | Same | Same | | Catheter Hub | Polycarbonate | Same | Same | | Marker Band | Platinum/Iridium | Same | Same | | Adhesive | Cyanoacrylate | Same | Same | | Outer Jacket Coating | Hydrophilic Coating | Same | Same | | Labeled Shaft Outer Diameter | Distal OD: 0.056 in Proximal OD: 0.058in | Distal OD: Vecta 71: 0.082 in. Vecta 74: 0.083 in. Proximal OD: Vecta 71: 0.085 in. Vecta 74: 0.087 in. | Same as Subject device | | Effective Lengths | 125, 146, 153, 160 cm | 115, 125, 132 cm | 153, 160 cm | | Distal ID | 0.046 in. | Vecta 71: 0.071 in. Vecta 74: 0.074 in. | Same as Subject device | | Proximal ID | 0.046 in. | Vecta 71: 0.071 in. Vecta 74: 0.074 in. | Same as Subject device | | Packaging Materials & Configuration | Tyvek/Nylon Pouch, polyethylene support tube, packaging card, SBS carton | Tyvek/Nylon Pouch, polyethylene support tube, packaging card, SBS carton | Same as Subject device | | Sterilization Method | EO Sterilization | Same | Same | | How Supplied | Single Use/Sterile | Same | Same…