Who is the manufacturer of Distal Access Catheter?

Shanghai Heartcare Medical Technology Co., Ltd. filed the 510(k) submission for Distal Access Catheter (K233205).

What is the FDA product code for Distal Access 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 Distal Access Catheter?

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

Who can help prepare an FDA 510(k) submission like Distal Access 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.

Distal Access Catheter

Q: What are the predicate devices for Distal Access Catheter?

AXS Catalyst™ Distal Access Catheter (K151667).

K233205 · Shanghai Heartcare Medical Technology Co., Ltd. · QJP · Dec 22, 2023 · Cardiovascular

Device Facts

Record ID	K233205
Device Name	Distal Access Catheter
Applicant	Shanghai Heartcare Medical Technology Co., Ltd.
Product Code	QJP · Cardiovascular
Decision Date	Dec 22, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.1250
Device Class	Class 2

Intended Use

The 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 Distal Access Catheter is also indicated for use as a conduit for retrieval devices.

Device Story

Sterile, single-lumen, variable-stiffness percutaneous catheter; used in peripheral and neurovascular systems. Features hydrophilic-coated distal shaft, radiopaque marker for angiographic visualization, and proximal luer hub. Available in straight or curved tip models. Operated by clinicians in clinical settings to facilitate insertion/guidance of interventional devices or as a conduit for retrieval devices. Provides physical pathway for interventional tools; aids in navigating vasculature; enables retrieval of materials. Benefits patient by allowing minimally invasive access to target vessels for therapeutic interventions.

Clinical Evidence

No clinical data. Substantial equivalence demonstrated through bench testing, including dimensional verification, tip buckling, flexural fatigue, trackability, lubricity/durability, particulate/coating integrity, tensile strength, leak testing, torque/kink resistance, flow rate, and biocompatibility (ISO 10993 series).

Technological Characteristics

Single-lumen catheter; materials: Pebax, Nylon, TPU shaft; Nickel-Titanium alloy braid; PTFE inner lumen; Platinum-Tungsten marker; Polycarbonate hub. Hydrophilic PVP coating. EO sterilized (SAL 10^-6). Dimensions: 5.4F/6.3F OD; 0.058"/0.071" ID. Standards: ISO 10555-1, ISO 80369-7, ASTM F640-12.

Indications for Use

Indicated for facilitating insertion and guidance of interventional devices into peripheral and neurovascular blood vessels and as a conduit for retrieval devices in patients requiring such 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 Catalyst™ Distal Access Catheter (K151667)

Reference Devices

AXS Catalyst Distal Access Catheter (AXS Catalyst 7) (K183463)

Related Devices

K250962 — APRO 55 Intermediate Catheter · Alembic, LLC · Apr 29, 2025
K234115 — APRO 55 Catheter · Alembic, LLC · Mar 15, 2024
K200206 — AXS Vecta 71 Intermediate Catheter, AXS Vecta 74 Intermediate Catheter · Stryker Neurovascular · Feb 27, 2020
K231218 — Distal Access Catheter · Accumedical Beijing , Ltd. · Jan 19, 2024
K251014 — APRO 45 Catheter · Alembic, LLC · May 1, 2025

Submission Summary (Full Text)

{0}------------------------------------------------ December 22, 2023 Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. Shanghai HeartCare Medical Technology Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co., Ltd. P.O. Box 120-119 Shanghai, 200120 China Re: K233205 Trade/Device Name: Distal Access Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: QJP, DQY Dated: September 25, 2023 Received: September 28, 2023 Dear Diana Hong: 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 (the 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 available 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. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). {1}------------------------------------------------ Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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, # Naira Muradyan -S Naira Muradyan, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health {2}------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ## Indications for Use 510(k) Number (if known) K233205 Device Name Distal Access Catheter The 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 Distal Access 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) ☐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."* Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 {3}------------------------------------------------ # 510(k) Summary This 510(k) Summary is being submitted in accordance with requirements of 21 CFR 807.92. 510(k) Number: K233205 Date of Preparation: 12/19/2023 #### Sponsor Identification 1. ### Shanghai HeartCare Medical Technology Co., Ltd. 590 Ruiging Rd, Building 4, Suite 201, East Zhangjiang High-Tech Park, Shanghai, P.R. China Contact Person: Hong Tianrong Position: Senior RA Manager Tel: +86-13671683981 Email: trhong@heartcare.com.cn #### Designated Submission Correspondent 2. Ms. Diana Hong (Primary Contact Person) Ms. Tingting Su (Alternative Contact Person) ### Mid-Link Consulting Co., Ltd P.O. Box 120-119, Shanghai, 200120, China Tel: +86-21-22815850, Fax: 360-925-3199 Email: info@mid-link.net #### Identification of Proposed Device 3. Trade Name: Distal Access Catheter Common Name: Percutaneous Catheter Regulatory Information Primary Product Code: QJP Classification Name: Catheter, Percutaneous, Neurovasculature Classification: II Regulation Number: 21 CFR 870.1250 {4}------------------------------------------------ Review Panel: Neurology Secondary Product Code: DQY Classification Name: Catheter, Percutaneous Classification: II Regulation Number: 21 CFR 870.1250 Review Panel: Cardiovascular #### 4. Identification of Predicate and Reference Devices Predicate Device: K151667 Device Name: AXS Catalyst™ Distal Access Catheter Reference Device: K183463 Device Name: AXS Catalyst Distal Access Catheter (AXS Catalyst 7) #### 5. Device Description The 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 a selected blood vessel in the peripheral and neurovascular systems. The catheter comes in Straight (with no shaping of the catheter tip) and Curved (curved catheter tip) models based on the distal end. The catheter shaft has a hydrophilic coating on the distal end of the shaft 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. #### 6. Indications for Use The 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 Distal Access Catheter is also indicated for use as a conduit for retrieval devices. {5}------------------------------------------------ # 7. Comparison of Technological Characteristics | ITEM | Subject Device K233205 Distal Access Catheter | Predicate Device K151667 AXS Catalyst™ Distal Access Catheter | Reference Device K183463 AXS Catalyst Distal Access Catheter (AXS Catalyst 7) | Remark | |-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------| | Classification | II | II | II | Same | | Regulation No. | 21 CFR 870.1250 | 21 CFR 870.1250 | 21 CFR 870.1250 | Same | | Code | QJP, DQY | DQY | DQY | Same | | Indication for Use | The 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 Distal Access Catheter is also indicated for use 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. | 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. | Same | | Inner Diameter (ID) | 0.058 inch; 0.071 inch | 0.058 inch; 0.060 inch | 0.068 inch | Similar | | Outer Diameter (OD) | 5.4F (0.071 inch); 6.3F (0.083 inch) | Distal: 5.3F (0.069 inch); 5.4F (0.071 inch) Proximal: 5.6F (0.073 inch); 6F (0.079 inch) | Distal: 6.2F (0.082 inch) Proximal: 6.3F (0.0825 inch) | Similar | | Effective Length | 95 cm; 105 cm; 115 cm; 125 cm; 130 cm | 115 cm; 132 cm | 115 cm; 125 cm; 132 cm | Similar | | Radiopaque Marker | Yes | Yes | Yes | Same | | Single Use | Yes | Yes | Yes | Same | | Accessories | None | Rotating Hemostasis Valve (RHV) Tuohy Borst valve with sideport Two peel away introducer sheaths | RHV Tuohy Borst valve with sideport Peel away introducer sheath | N/A | | Maximum Guidewire OD | 0.035 inch | 0.038 inch | 0.038 inch | Similar | | | Table 1: Comparison of Technological Characteristics | | |--|------------------------------------------------------|--| | | | | {6}------------------------------------------------ | Materials | | | | | |-----------------------------------------------------------|------------------------------------------------|-----------------------------------------------------|--------------------------------------|------------------------------------------------------------------------------------| | Shaft (Outer Surface) | Pebax; Nylon; Thermoplastic Urethanes (TPU) | Pebax; Nylon; Tecoflex | Pebax; Nylon; Tecoflex | The differences do not raise new questions of safety or effectiveness. | | Shaft (Metal Braid) | Nickel-Titanium alloy | Stainless steel, Nitinol wire, and polymer fiber | Nitinol wire and polymer fiber | | | Shaft (Inner Lumen) | Polytetrafluoroethylene (PTFE) | PTFE | PTFE | | | Hydrophilic Coating | Polyvinylpyrrolidone (PVP) | Hydrophilic coating | Hydrophilic coating | The subject device has been evaluated | | Marker | Platinum-Tungsten alloy | Platinum/Iridium | Platinum/Iridium | | | Hub | Polycarbonate (PC) | Nylon | Nylon | through bench | | Heat Shrink Tube and Stainless Steel Diffusion Tube | Polyolefin and 304 Stainless Steel | Thermoplastic rubber (Santoprene) | Thermoplastic rubber (Polyolefin) | and biocompatibility testing. | | Sterilization | | | | | | Method | Ethylene Oxide (EO) sterilized | EO sterilized | EO sterilized | Same | | Sterility Assurance Level (SAL) | 10-6 | 10-6 | 10-6 | Same | {7}------------------------------------------------ #### 8. Non-Clinical Performance Testing The results of verification and validation testing conducted on the Distal Access Catheter demonstrate that it performs as designed and is substantially equivalent to the predicate. A summary of the tests performed is provided in the table below: | Test | Test Method / Applicable Standard | Test Results | |-------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------| | Dimensional Verification | Verify dimensions using specified measurement tool. | Pass | | Tip Configuration | Visually inspect distal tip at 10x magnification. | Pass | | Surface Integrity | Inspect catheter surface. ISO 10555-1:2013 | Pass | | Tip Buckling | Use a testing apparatus to measure the maximum force required to cause a test sample to buckle at 5 mm, 10 mm and 20 mm from distal tip. | Pass | | Luer Connector Tests | ISO 80369-7: 2021 | Pass | | Flexural Fatigue | After ten runs of the Distal Access Catheter with the accessories in the simulated use model, remove the test sample and inspect the sample for kinks or damage. | Pass | | Trackability | Test the peak tracking force and the compatibility with the ancillary devices during insertion and retraction of the catheter in the simulated use model. | Pass | | Catheter Lubricity and Durability | Use friction tester to measure the frictional force of the test samples when pulled between two clamped pads. Record the peak frictional force over 5 cycles. | Pass | | Particulate and Coating Integrity Test | Measure the size and number of particulates generated during simulated use and conduct visual inspection at 50x and 200x magnification of the outer surface of the catheter after simulated use. | Pass | | Tensile Strength Test | ISO 10555-1:2013 | Pass | | Air Leakage | ISO 10555-1:2013 | Pass | | Liquid Leakage | ISO 10555-1:2013 | Pass | | Torque Resistance | Fix the distal tip of the Distal Access Catheter and rotate the proximal end until the Distal Access Catheter shows kink or other signs of failure. | Pass | | Kink Resistance Test | Visually inspect whether the Distal Access Catheter kinks or not when wrapped around mandrels with diameters 1 mm to 10 mm (in 1 mm increments). | Pass | | Catheter Tip and Lumen Integrity | After simulated use, aspirate test sample for 10 sec using a 60 cc syringe during retrieval device withdrawal. Visually inspect the test sample to verify absence of tip or lumen collapse. | Pass | {8}------------------------------------------------ | Corrosion Resistance Test | ISO 10555-1:2013 | Pass | |------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------| | Tip Flexibility Test | Use a mechanical force meter to push the tip from left to right at 5 mm, 10 mm, and 20 mm from the distal tip. | Pass | | Radiopacity | ASTM F640-12 | Pass | | Static Burst Pressure | ISO 10555-1:2013 | Pass | | Compatibility Test | The compatibility of the Distal Access Catheter with a marketed introducer sheath, guide catheter, guidewire, micro guidewire, microcatheter, and stent-retriever is evaluated. | Pass | | Flow Rate | Use a flow rate tester to measure the flow rate of the Distal Access Catheter. | Pass | ### Biocompatibility The Distal Access Catheter is categorized as Externally Communicating Device, Limited Contact (≤ 24 hours) with Circulating Blood, per ISO 10993-1, the following tests were conducted: | | Standard Utilized / | | | Test Results | |-----------------------------------------|--------------------------------------|-------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|--------------| | Test | Section | Method | Acceptance Criteria | (Pass/Fail) | | Cytotoxicity | ISO 10993-5: 2009 | MTT Method | Viability > 70% | Pass | | Skin Sensitization | ISO 10993-10: 2010 | Guinea Pig Maximization Test (GPMT) | Magnusson & Kligman grades < 1 | Pass | | Intracutaneous Reactivity Test | ISO 10993-10: 2010 | Intracutaneous Reactivity Study (Dermal) | Score < 1.0 | Pass | | Acute Toxicity | ISO 10993-11: 2017 | Acute Toxicity in Mice | No acute toxicity | Pass | | Rabbit Pyrogen | ISO 10993-11: 2017 | Rabbit Pyrogen Study, Material Mediated | None of the animals showed a significantly greater reaction than the corresponding control animals. | Pass | | Complement Activation | ISO 10993-4: 2017 | In Vivo Thromboresistance Study in the Dog NAVI Mode | The thrombus formation score shall not be higher than control. | Pass | | In Vivo Thromboresistance | ISO 10993-4: 2017 | In Vivo Thromboresistance Study in the Dog NAVI Mode | The thrombus formation score shall not be higher than control. | Pass | | ASTM Hemolysis | ASTM F756-2017 | ASTM Hemolysis Study Direct Contact and Indirect Contact | Hemolytic Index 0 - < 2% Non-Hemolytic | Pass | | Bacterial Reverse Mutation | ISO 10993-3: 2014 | Bacterial Reverse Mutation Test | No mutation effects | Pass | | In Vitro Mammalian Cell Mutation | ISO 10993-3: 2014 | Thymidine Kinase Gene | No mutation effect | Pass | | Partial Thromboplastin Time Study | ISO 10993-4: 2017 ASTM F2382-2018 | Partial Thromboplastin Time Study | No statistically significant difference between test article and control article or the negative reference control. | Pass | ### Sterilization and Shelf Life The Distal Access Catheter sterilization process using Ethylene Oxide (EO) has been validated in accordance with ISO 11135:2014 to achieve a sterility assurance level (SAL) of 10 6. EO and Ethylene {9}------------------------------------------------ Chlorohydrin (ECH) residuals were below the limits specified in ISO 10993-7:2008. Bacterial Endotoxin Levels were below the level of 2.15 EU/device in accordance with USP <85>. Both baseline and accelerated shelf-life testing were conducted demonstrating the device will perform as intended to support the proposed 2-year shelf-life. #### Clinical Performance Testing 9. No clinical studies were necessary to demonstrate substantial equivalence. ### 10. Conclusion The subject device, Distal Access Catheter, has similar technological characteristics and the same intended use as the predicate device, AXS Catalyst Distal Access Catheter (K151667). The differences in technological characteristics do not raise new or different questions of safety or effectiveness. The successful completion of bench performance, biocompatibility, and sterility testing demonstrates that the subject device performs as intended and is substantially equivalent to the predicate.