APRO 35 Swift Catheter

K262392 · Alembic, LLC · DQY · Aug 12, 2026 · Cardiovascular

Device Facts

• Record ID: K262392
• Device Name: APRO 35 Swift Catheter
• Applicant: Alembic, LLC
• Product Code: DQY · Cardiovascular
• Decision Date: Aug 12, 2026
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The APRO® 35 Swift 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 APRO® 35 Swift Catheter is also indicated for use as a conduit for retrieval devices.

Device Story

Single-lumen, braid and coil reinforced catheter; used to facilitate insertion/guidance of interventional devices into peripheral and neurovasculature; functions as conduit for retrieval devices. Operated by clinicians under fluoroscopic guidance; introduced through guide catheter/sheath over guidewire. Features hydrophilic coating on distal shaft for navigation; radiopaque marker at distal tip for visualization. Output is physical access to target vasculature; enables delivery of interventional tools or retrieval of clots. Benefits patient by providing minimally invasive access to neurovascular/peripheral sites for therapeutic intervention.

Clinical Evidence

No clinical data. Substantial equivalence established through non-clinical bench testing, including visual/dimensional inspection, particulate testing, kink resistance, hub air/liquid leakage, hub compatibility (ISO 80369-7), torque strength, dynamic/static burst pressure, tensile strength, 3-point bend, delivery/retrieval force, simulated use in neurovascular models, and corrosion resistance (ISO 10555-1). Biocompatibility evaluated per ISO 10993-1 via comparative surface/geometry assessment.

Technological Characteristics

Single-lumen catheter; braid/coil reinforced (304V stainless steel). Materials: Nylon hub, cyanoacrylate adhesive, Santoprene strain relief, PTFE/Pebax liner, polyether block amide extrusions, platinum/iridium marker band. Hydrophilic coating. Dimensions: 0.049" proximal OD, 0.047" distal OD, 0.035" ID. Sterilization: Ethylene Oxide (ISO 11135). Connectivity: None (mechanical device).

Indications for Use

Indicated for adult patients requiring insertion and guidance of interventional devices into peripheral and neurovascular blood vessels, or as a conduit for retrieval devices.

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

• APRO® 45 Catheter (K251014)

Submission Summary (Full Text)

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**FDA** U.S. FOOD & DRUG
ADMINISTRATION

August 12, 2026

Alembic, LLC
Stina Almaleh
Senior Regulatory and Quality Assurance Engineer
627 National Avenue
Mountain View, California 94043

Re: K262392

Trade/Device Name: APRO 35 Swift Catheter
Regulation Number: 21 CFR 870.1250
Regulation Name: Percutaneous Catheter
Regulatory Class: Class II
Product Code: DQY, QJP
Dated: July 13, 2026
Received: July 14, 2026

Dear Stina Almaleh:

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.

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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K262392 - Stina Almaleh

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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).

Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).

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 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-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-

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K262392 - Stina Almaleh

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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

NAIRA MURADYAN -S

Naira Muradyan, PhD

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

Enclosure

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| Indications for Use | | |
| --- | --- | --- |
| Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K262392 | ? |
| Please provide the device trade name(s). | | ? |
| APRO® 35 Swift Catheter | | |
| Please provide your Indications for Use below. | | ? |
| The APRO® 35 Swift 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 APRO® 35 Swift Catheter is also indicated for use as a conduit for retrieval devices. | | |
| Please select the types of uses. | ☑ Prescription Use (21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ? |
| Please select the age group(s) for which the device(s) is to be used. | ☐ Neonates/Newborns (Birth to < 29 days old) ☐ Infants (29 days old to < 2 years old) ☐ Children (2 years old to < 12 years old) ☐ Adolescents (12 years old to < 22 years old) ☑ Adults (22 years old and greater) | ? |

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510(k) Number: K262392

ALEMBIC

# 510(K) SUMMARY

This 510(k) Summary is provided in accordance with the requirements of 21 CFR §807.92.

# 1) Submitter Information

Submitter:

Alembic, LLC
627 National Ave.
Mountain View, CA 94043

Contact:

Stina Almaleh
Senior Regulatory and Quality Assurance Engineer
Email: [e-mail]
Telephone Number: [phone]

Date Prepared:

August 11, 2026

# 2) Device Name and Classification

Trade/Proprietary Name:

APRO® 35 Swift Catheter

Common Name:

Percutaneous Catheter

Classification Name:

Percutaneous Catheter, 21 CFR 870.1250
Catheter, Percutaneous, Neurovasculature, 21 CFR 870.1250

Regulatory Class:

Class II

Product Codes:

DQY, QJP

Review Panel:

Cardiovascular, Neurology

# 3) Legally Marketed Predicate Device

Predicate Device:

K251014 APRO® 45 Catheter

# 4) Device Description

The APRO® 35 Swift Catheter is a single-lumen, braid and coil reinforced catheter. The APRO® 35 Swift Catheter is designed to facilitate the insertion and guidance of interventional devices into peripheral and neuro vasculature. Using standard catheterization techniques under fluoroscopic guidance, the APRO® 35 Swift Catheter is introduced through a guide catheter or guide sheath and over a guidewire into the target vasculature. The distal segment of the catheter shaft has a hydrophilic coating to aid navigation through the vasculature. A radiopaque marker is located at the distal tip of the catheter for visualization under fluoroscopy. The APRO® 35 Swift Catheter is provided with an Introducer Sheath.

# 5) Indications for Use

The APRO® 35 Swift 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 APRO® 35 Swift Catheter is also indicated for use as a conduit for retrieval devices.

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APRO® 35 Swift Catheter

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510(k) Number: K262392

ALEMBIC

# 6) Technological Characteristics Comparison

Alembic has demonstrated that the APRO® 35 Swift Catheter is substantially equivalent to the predicate device APRO® 45 Catheter based on the similarity in materials, similarity in design concept, and the same fundamental operating principles. A comparison of the APRO® 35 Swift Catheter with the predicate is summarized in Table 1 below.

Table 1. APRO® 35 Swift Catheter Comparison with the Predicate Device

| Category | Subject Device APRO® 35 Swift Catheter | Predicate Device APRO® 45 Catheter |
| --- | --- | --- |
| 510(k) Number | K262392 | K251014 |
| Regulatory Class | **Same as predicate.** | Class II, 21 CFR 870.1250, DQY, QJP |
| Indications for Use | The APRO® 35 Swift 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 APRO® 35 Swift Catheter is also indicated for use as a conduit for retrieval devices. | The APRO® 45 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 APRO® 45 Catheter is also indicated for use as a conduit for retrieval devices. |
| Principles of Operation | **Same as predicate.** | Using conventional catheterization techniques under fluoroscopic guidance, the catheter is advanced into the target vessel over an appropriate neurovascular guidewire. |
| **Materials** | | |
| Hub | **Same as predicate.** | Nylon |
| Adhesive | **Same as predicate.** | Cyanoacrylate |
| Strain Relief | **Same as predicate.** | Santoprene (thermoplastic elastomer) |
| Liner | **Same as predicate.** | Polytetrafluoroethylene (PTFE)/Pebax composite |
| Shaft Coil or Braid | **Same as predicate.** | 304V stainless steel braid 304V stainless steel coil |
| Extrusions | **Same as predicate.** | Polyether block amide |
| Marker Band | **Same as predicate.** | Platinum/ iridium |
| Coating | **Same as predicate.** | Hydrophilic coating |
| **Dimensions** | | |
| Proximal Outer Diameter | 0.049 inch | 0.060 inch |
| Distal Outer Diameter | 0.047 inch | 0.058 inch |
| Inner Diameter | 0.035 inch | 0.045 inch |
| Effective Lengths | 125, 146, 160 cm | 115, 125, 146, 160 cm |
| Coated Length | 90 cm | 60 cm |
| Tip Shape | **Same as predicate.** | Straight |
| **Accessories** | | |
| Introducer Sheath | **Same as predicate.** | Yes |
| **Packaging Materials** | | |
| Pouch | **Same as predicate.** | Nylon/Polyethylene/Tyvek |
| Packaging Hoop Coil | **Same as predicate.** | Polyethylene |

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APRO® 35 Swift Catheter

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510(k) Number: K262392

ALEMBIC

Table 1. APRO® 35 Swift Catheter Comparison with the Predicate Device

| Category | Subject Device APRO® 35 Swift Catheter | Predicate Device APRO® 45 Catheter |
| --- | --- | --- |
| Packaging Card | Same as predicate. | Polyethylene |
| Shelf Carton | Same as predicate. | Solid bleached sulfate paperboard |
| **Other** | | |
| Sterilization | Same as predicate. | Ethylene Oxide |
| Shelf Life | Same as predicate. | 1 year |
| Use Conditions | Same as predicate. | Sterile, single use, disposable |

# 7) Performance Data

Alembic performed non-clinical bench, sterility, shelf-life, and biocompatibility testing. The results demonstrate substantial equivalence of the subject APRO® 35 Swift Catheter to the legally marketed predicate device.

# A. Design Verification Testing – Non-Clinical Bench

Performance testing was conducted to support the APRO® 35 Swift Catheter submission. The results of the design verification and validation testing confirm that the APRO® 35 Swift Catheter conforms to the predefined specifications and meets the test acceptance criteria. A summary of the testing is shown in Table 2.

Table 2. Summary of Non-Clinical Bench Test Results

| Test | Acceptance Criteria | Conclusion |
| --- | --- | --- |
| Visual and Dimensional Characteristics | Catheter meets the visual and dimensional specifications. | The APRO® 35 Swift Catheter met the acceptance criteria. |
| Particulate | Catheter meets the acceptance criteria. Subject device was evaluated with a predicate device under the same test conditions. | The APRO® 35 Swift Catheter met the acceptance criteria. |
| Kink Resistance | Catheter shaft shall not kink at clinically relevant radii. | The APRO® 35 Swift Catheter met the acceptance criteria. |
| Hub Air Leakage | Catheter does not leak air into hub assembly with methods specified in ISO 10555-1, Annex D. | The APRO® 35 Swift Catheter met the acceptance criteria. |
| Hub Compatibility | Catheter meets the requirements specified in ISO 80369-7. | The APRO® 35 Swift Catheter met the acceptance criteria. |
| Torque Strength | Catheter must withstand the minimum required number of rotations without breakage and without kinking compared to legally marketed devices. | The APRO® 35 Swift Catheter met the acceptance criteria. |
| Dynamic Burst Pressure | No damage to catheter with dynamic pressure. | The APRO® 35 Swift Catheter met the acceptance criteria. |
| Liquid Leakage | Catheter must withstand pressure with methods specified in ISO 10555-1, Annex C. | The APRO® 35 Swift Catheter met the acceptance criteria. |
| Static Burst | Catheter must withstand pressures anticipated for clinical use. | The APRO® 35 Swift Catheter met the acceptance criteria. |
| Hub and Shaft Tensile Strength | Catheter hub and shaft must meet tensile strength specification. | The APRO® 35 Swift Catheter met the acceptance criteria. |
| Tip Tensile Strength | Catheter tip must meet tip tensile strength specification. | The APRO® 35 Swift Catheter met the acceptance criteria. |

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APRO® 35 Swift Catheter

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510(k) Number: K262392

ALEMBIC

Table 2. Summary of Non-Clinical Bench Test Results

| Test | Acceptance Criteria | Conclusion |
| --- | --- | --- |
| 3-Point Bend | Catheter 3-Point Bend force must be acceptable. Forces were compared to the predicate. | The APRO® 35 Swift Catheter met the acceptance criteria. |
| Delivery and Retrieval Force | Catheter delivery and retrieval force must be acceptable. Forces were compared to the predicate. | The APRO® 35 Swift Catheter met the acceptance criteria. |
| Simulated Use | When used per the Instructions for Use with accessory devices in an anatomical neurovascular model and during simulated clot retrieval, the Catheter must meet functionality specifications including compatibility with a stent retriever. | The APRO® 35 Swift Catheter met the acceptance criteria. |
| Corrosion Resistance | Catheter shall show no signs of corrosion when tested in accordance with ISO 10555-1, Annex A. | The APRO® 35 Swift Catheter met the acceptance criteria. |

### B. Design Verification Testing – Animal

Substantial equivalence was established based on non-clinical bench performance data. Animal testing data were not deemed necessary.

### C. Sterilization and Shelf-Life

The APRO® 35 Swift Catheter is sterilized using an ethylene oxide sterilization cycle that was verified to a sterility assurance level of 1 x 10⁻⁶ in accordance with ISO 11135. Aging studies for the APRO® 35 Swift Catheter have established that the subject device and packaging remain functional for the labeled expiration date. Aging studies for packaging integrity, seal strength, and the device functionality were performed and met the acceptance criteria.

### D. Biocompatibility

Biological safety evaluation was conducted for the APRO® 35 Swift Catheter in accordance with ISO 10993-1 and the FDA Guidance, “Use of International Standard ISO 10993-1, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process”.”

Additionally, the risk management process determined that the biocompatibility testing conducted on the predicate device APRO® 45 Catheter (K251014) per ISO 10993-1 and applicable regulatory requirements, adequately assesses the biocompatibility profile of the subject APRO® 35 Swift Catheter for endpoints recommended by the FDA biocompatibility guidance for an externally communicating device with limited (≤24 hours) duration of contact with circulating blood. Additionally, a comparative assessment of the subject APRO® 35 Swift Catheter and predicate APRO® 45 Catheter did not identify any significant differences in the surface characteristics or geometry of these devices as summarized in Table 3.

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APRO® 35 Swift Catheter

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510(k) Number: K262392

ALEMBIC

Table 3. Summary of Biocompatibility Test Results

| Test | Results | Conclusions |
| --- | --- | --- |
| Thrombogenicity – Comparative Surface and Geometry Assessment | Comparative surface assessment using 40x optical microscopy at representative locations of the subject device and the predicate device did not find any differences in the roughness or presence of any defects. The subject device has similar surface morphology to the predicate device APRO® 45 Catheter. | Non-thrombogenic. |

# E. Clinical Testing

Substantial equivalence was established based on non-clinical performance data. Human clinical data were not deemed necessary.

# 8) Conclusion

Based on the comparison of the technological characteristics and the non-clinical testing, the subject device is found to be substantially equivalent to the predicate device. The differences in technological characteristics do not raise new questions of safety and effectiveness. Testing was conducted to demonstrate that the subject device meets the specifications and performs as intended.

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APRO® 35 Swift Catheter