(264 days)
The Sangria™ Thrombectomy System is intended for removal of fresh, soft emboli and thrombi from vessels of the peripheral venous system ≥ 7mm in diameter.
The Sangria™ Thrombectomy System (Sangria™ System) is a sterile, single-use, percutaneous, 14 Fr catheter-based system (single-piece construction) designed for the removal of fresh, soft emboli and thrombi from vessels of the peripheral venous systems. The 14Fr, over-the-wire Catheter features a battery-operated handle with a slider that deflects the Catheter to target thrombus. A power switch on the handle activates rotation of the tip. Once activated, the tip rotates to break down the thrombus, which is then cleared proximally through the Catheter lumen and aspiration port into an external canister via vacuum aspiration. The Catheter is offered in a Straight Sheath configuration.
N/A
FDA 510(k) Clearance Letter - Sangria™ Thrombectomy System
Page 1
January 7, 2026
Avantec Vascular Corporation
Gene Reu
Vice President Commercialization
870 Hermosa Drive
Sunnyvale, California 94085
Re: K251207
Trade/Device Name: Sangria™ Thrombectomy System
Regulation Number: 21 CFR 870.5150
Regulation Name: Embolectomy Catheter
Regulatory Class: Class II
Product Code: QEW, BTA
Dated: April 17, 2025
Received: April 18, 2025
Dear Gene Reu:
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.
January 7, 2026
Avantec Vascular Corporation
Gene Reu
Vice President Commercialization
870 Hermosa Drive
Sunnyvale, California 94085
Re: K251207
Trade/Device Name: Sangria™ Thrombectomy System
Regulation Number: 21 CFR 870.5150
Regulation Name: Embolectomy Catheter
Regulatory Class: Class II
Product Code: QEW, BTA
Dated: April 17, 2025
Received: April 18, 2025
Dear Gene Reu:
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.
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K251207 - Gene Reu Page 2
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 System (QS) 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 (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 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.
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-
Page 3
K251207 - Gene Reu Page 3
assistance/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,
GREGORY W. O'CONNELL -S
Digitally signed by GREGORY W. O'CONNELL -S
Date: 2026.01.07 14:09:24 -05'00'
Gregory O'Connell
Assistant Director
DHT2C: Division of Coronary and Peripheral Intervention Devices
OHT2: Office of Cardiovascular Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
Indications for Use
See PRA Statement below.
510(k) Number (if known)
K251207
Device Name
Sangria™ Thrombectomy System
Indications for Use (Describe)
The Sangria™ Thrombectomy System is intended for removal of fresh, soft emboli and thrombi from vessels of the peripheral venous system ≥ 7mm in diameter.
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)
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:
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"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 FDA 3881 (6/20) Page of PSC Publishing Services (301) 443-6740 EF
Page 5
Traditional 510(k) Notification K251207
Sangria Thrombectomy System
Sangria System 510(k) Summary
510(k) Summary
This 510(k) Summary was prepared in accordance with 21 CFR 807.92.
I. Submitter
Avantec Vascular Corporation
870 Hermosa Drive
Sunnyvale, CA 94085
Contact Person
Gene Reu
Vice President of Commercialization
Telephone: +1 (858) 945-0007
Email: GReu@avantecvascular.com
Date Prepared
December 5, 2025
II. Device
Trade Name: Sangria™ Thrombectomy System
Common Name: Rotational/Aspirational Thrombectomy
Classification Name: Embolectomy catheter
Regulation Number: 21 CFR 870.5150
Product Code: QEW, BTA
Device Class: Class II
Classification Panel: Cardiovascular
III. Predicate Device
Predicate Device: QuickClear Mechanical Thrombectomy System (K193197)
Reference Device: Cleaner 15/Cleaner XT Rotational Thrombectomy System (K141617)
IV. Device Description
The Sangria™ Thrombectomy System (Sangria™ System) is a sterile, single-use, percutaneous, 14 Fr catheter-based system (single-piece construction) designed for the removal of fresh, soft emboli and thrombi from vessels of the peripheral venous systems. The 14Fr, over-the-wire Catheter features a battery-operated handle with a slider
Page 1 of 5
Page 6
Traditional 510(k) Notification K251207
Sangria Thrombectomy System
Sangria System 510(k) Summary
Page 2 of 5
that deflects the Catheter to target thrombus. A power switch on the handle activates rotation of the tip. Once activated, the tip rotates to break down the thrombus, which is then cleared proximally through the Catheter lumen and aspiration port into an external canister via vacuum aspiration. The Catheter is offered in a Straight Sheath configuration.
V. Indications for Use
The Sangria™ Thrombectomy System is intended for removal of fresh, soft emboli and thrombi from vessels of the peripheral venous system ≥ 7mm in diameter.
VI. Comparison of Technological Characteristics with the Predicate Device
The Sangria™ Thrombectomy System has similar features as compared to the predicate device and reference device as shown in the following table:
| Subject Device | Predicate Device | Reference Device |
|---|---|---|
| Manufacturer | Avantec Vascular | Philips |
| Device Name | Sangria Thrombectomy System | QuickClear Mechanical Thrombectomy System |
| 510(k) Number | K251207 | K193197 |
| Indication for Use | The Sangria™ Thrombectomy System is intended for removal of fresh, soft emboli and thrombi from vessels of the peripheral venous system ≥ 7mm in diameter. | The QuickClear Mechanical Thrombectomy System is intended for removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems. |
| Classification Name | Embolectomy Catheter | Embolectomy Catheter |
| Regulation Description | Embolectomy Catheter | Embolectomy Catheter |
| Regulation Number | 21 CFR 870.5150 | 21 CFR 870.5150 |
| Product Code | QEW/BTA | QEZ |
| Regulatory Class | Class II | Class II |
| Product Code Description | Peripheral Mechanical Thrombectomy With Aspiration | Aspiration Thrombectomy Catheter |
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Traditional 510(k) Notification K251207
Sangria Thrombectomy System
Sangria System 510(k) Summary
that deflects the Catheter to target thrombus. A power switch on the handle activates rotation of the tip. Once activated, the tip rotates to break down the thrombus, which is then cleared proximally through the Catheter lumen and aspiration port into an external canister via vacuum aspiration. The Catheter is offered in a Straight Sheath configuration.
V. Indications for Use
The Sangria™ Thrombectomy System is intended for removal of fresh, soft emboli and thrombi from vessels of the peripheral venous system ≥ 7mm in diameter.
VI. Comparison of Technological Characteristics with the Predicate Device
The Sangria™ Thrombectomy System has similar features as compared to the predicate device and reference device as shown in the following table:
| Subject Device | Predicate Device | Reference Device | |
|---|---|---|---|
| Manufacturer | Avantec Vascular | Philips | Argon Medical Devices |
| Device Name | Sangria Thrombectomy System | QuickClear Mechanical Thrombectomy System | Cleaner (Cleaner 15/Cleaner XT) Rotational Thrombectomy System |
| 510(k) Number | K251207 | K193197 | K141617 |
| Indication for Use | The Sangria™ Thrombectomy System is intended for removal of fresh, soft emboli and thrombi from vessels of the peripheral venous system ≥ 7mm in diameter. | The QuickClear Mechanical Thrombectomy System is intended for removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems. | The Cleaner Rotational Thrombectomy System is indicated for mechanical declotting of native vessel dialysis fistulae and synthetic dialysis access grafts. The Cleaner Rotational Thrombectomy System is indicated for mechanical declotting and controlled and selective infusion of physician-specific fluids, including thrombolytics, in the peripheral vasculature. |
| Classification Name | Embolectomy Catheter | Embolectomy Catheter | Embolectomy Catheter |
| Regulation Description | Embolectomy Catheter | Embolectomy Catheter | Embolectomy Catheter/Continuous Flush Catheter |
| Regulation Number | 21 CFR 870.5150 | 21 CFR 870.5150 | 21 CFR 870.5150 |
| Product Code | QEW/BTA | QEZ | QEW/KRA |
| Regulatory Class | Class II | Class II | Class II |
| Product Code Description | Peripheral Mechanical Thrombectomy With Aspiration | Aspiration Thrombectomy Catheter | Peripheral Mechanical Thrombectomy With |
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Traditional 510(k) Notification K251207
Sangria Thrombectomy System
Sangria System 510(k) Summary
Page 3 of 5
| Aspiration / Catheter, Continuous Flush | |||
|---|---|---|---|
| Mechanism of Action | Mechanical maceration and removal of embolic and thrombus with tip rotation activated by ON/OFF switch, aided by aspiration pump | Continuous aspiration and removal of emboli and thrombus with aspiration pump | Mechanical maceration by a sinusoidal wire with rotation activated by ON/OFF switch and deployment of wire by slider lever |
| Rotational Speed | 200-270 rpm | N/A | 4000 rpm |
| Guidewire Exchange | Over-the-wire | Over-the-wire | Over-the-wire |
| Guidewire Compatibility | 0.035" | 0.035" | 0.035" |
| Catheter Working Length | 110cm | 130 cm (6Fr) 85 cm (8Fr) 85 cm (10Fr) | 65 cm (6Fr, 7Fr) 135 cm (6Fr, 7Fr) |
| Tip Diameter | .177" | 0.084-0.088" (8Fr) 0.104-0.108" (10Fr) | Sinusoidal maceration wire diameter: 0.035" 0.044" |
| Catheter Outer Diameter | .185" (14Fr) | 0.079" (6Fr) 0.105" (8Fr) | 6Fr 7Fr |
| Target Vessel Diameters | ≥ 7.0mm (14Fr) | > 3.0mm (6Fr) > 4.0mm (8Fr) > 5.0mm (10Fr) | > 6mm (Cleaner 15) |
| Debris Collection & Removal | Continuous aspiration and removal of emboli and thrombus via a vacuum aspiration source | Continuous collection and removal of emboli and thrombus via a vacuum aspiration source with the catheter targeted at thrombus in the peripheral vasculature | N/A – no collection/removal through the Catheter |
| Tip Configuration | Deflectable, open spoon shape tip | Open catheter lumen, straight or shaped tip (deflected): 6Fr – Straight 8Fr – Shaped 10Fr – Shaped | Conical shape tip and sinusoidal shaped wire 6Fr: 9mm sinusoidal amplitude 7Fr: 15mm sinusoidal amplitude |
| Radiopacity | Radiopaque tip | Radiopaque marker band at tip | Radiopaque tip |
| Deflection Mechanism | Advancement and retraction of outer sheath | None | None |
| Recommended Vacuum Range | -100 mmHg to -250 mmHg | Capable of providing a vacuum source of ≥ 25inch Hg | N/A |
| Vacuum Source | Up to -22 inch Hg | Vacuum ≥ 25 inch Hg Vacuum | N/A |
| Waste Collection Source | Collection Canister | Collection Bag | N/A |
| Catheter Coating | No | Yes | No |
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Traditional 510(k) Notification K251207
Sangria Thrombectomy System
Sangria System 510(k) Summary
Page 4 of 5
| Aspiration / Catheter, Continuous Flush | |||
|---|---|---|---|
| Mechanism of Action | Mechanical maceration and removal of embolic and thrombus with tip rotation activated by ON/OFF switch, aided by aspiration pump | Continuous aspiration and removal of emboli and thrombus with aspiration pump | Mechanical maceration by a sinusoidal wire with rotation activated by ON/OFF switch and deployment of wire by slider lever |
| Rotational Speed | 200-270 rpm | N/A | 4000 rpm |
| Guidewire Exchange | Over-the-wire | Over-the-wire | Over-the-wire |
| Guidewire Compatibility | 0.035" | 0.035" | 0.035" |
| Catheter Working Length | 110cm | 130 cm (6Fr) 85 cm (8Fr) 85 cm (10Fr) | 65 cm (6Fr, 7Fr) 135 cm (6Fr, 7Fr) |
| Tip Diameter | .177" | 0.084-0.088" (8Fr) 0.104-0.108" (10Fr) | Sinusoidal maceration wire diameter: 0.035" 0.044" |
| Catheter Outer Diameter | .185" (14Fr) | 0.079" (6Fr) 0.105" (8Fr) | 6Fr 7Fr |
| Target Vessel Diameters | ≥ 7.0mm (14Fr) | > 3.0mm (6Fr) > 4.0mm (8Fr) > 5.0mm (10Fr) | > 6mm (Cleaner 15) |
| Debris Collection & Removal | Continuous aspiration and removal of emboli and thrombus via a vacuum aspiration source | Continuous collection and removal of emboli and thrombus via a vacuum aspiration source with the catheter targeted at thrombus in the peripheral vasculature | N/A – no collection/removal through the Catheter |
| Tip Configuration | Deflectable, open spoon shape tip | Open catheter lumen, straight or shaped tip (deflected): 6Fr – Straight 8Fr – Shaped 10Fr – Shaped | Conical shape tip and sinusoidal shaped wire 6Fr: 9mm sinusoidal amplitude 7Fr: 15mm sinusoidal amplitude |
| Radiopacity | Radiopaque tip | Radiopaque marker band at tip | Radiopaque tip |
| Deflection Mechanism | Advancement and retraction of outer sheath | None | None |
| Recommended Vacuum Range | -100 mmHg to -250 mmHg | Capable of providing a vacuum source of ≥ 25inch Hg | N/A |
| Vacuum Source | Up to -22 inch Hg Vacuum | ≥ 25 inch Hg Vacuum | N/A |
| Waste Collection Source | Collection Canister | Collection Bag | N/A |
| Catheter Coating | No | Yes | No |
| Aspiration Tubing Inner Diameter | .250" | 0.100 – 0.125" | N/A |
| Biocompatibility | Per ISO 10993-1 | Per ISO 10993-1 | Per ISO 10993-1 |
| Sterilization | Electron Beam Irradiation | Ethylene Oxide | Ethylene Oxide |
| Single Use Only | Yes | Yes | Yes |
VII. Performance Data
To demonstrate the substantial equivalence of the subject Sangria Thrombectomy System to the selected predicate device, the performance and technological characteristics were evaluated by completion of the following bench tests:
Bench Testing
- Dimensional Inspection
- Visual Inspection
- Simulated Use
- Simulated Debulking/Declotting
- Catheter Kink Resistance
- Corrosion Resistance
- Catheter Joint/Tensile Strength
- Catheter Torque Strength
- Temperature Rise
- Run Time
- Aspiration Catheter Tests
- Guidewire Compatibility
- Device integrity and functionality as part of Shelf Life and Packaging Validation Testing
Biocompatibility
The following biocompatibility tests were conducted on the Sangria Thrombectomy System according to ISO 10993-1 Biological Evaluation of Medical Devices - Part 1: Evaluation and testing within a risk management process.
- Cytotoxicity: ISO Elution Method
- Sensitization: Magnusson-Kligman Method
- Irritation or Intracutaneous Toxicity (ISO)
- Acute Systemic Toxicity (ISO)
- Hemocompatibility:
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Traditional 510(k) Notification K251207
Sangria Thrombectomy System
Sangria System 510(k) Summary
Page 5 of 5
- in vivo Thrombogenicity
- Complement Activation, SC5b-9
- Partial Thromboplastin Time (PTT)
- Hemolysis, Direct and Extract Methods (ISO)
- Material Mediated Pyrogenicity
Animal Testing
Two GLP animal studies were performed to evaluate the safety and performance of the Sangria™ Thrombectomy System as compared to the reference device, the Cleaner (Cleaner 15/Cleaner XT) Rotational Thrombectomy System (K141617) in a porcine model. Based on the results of the testing and histopathology findings, the safety and performance objectives for the studies were met.
Sterilization Validation
Sterilization validation was conducted on the Sangria™ Thrombectomy System and demonstrated a sterility assurance level of 10⁻⁶.
Electrical Safety and Electromagnetic Compatibility (EMC)
Electrical Safety and EMC testing was conducted on the Sangria™ Thrombectomy System and complies with IEC 60601-1 and IEC 60601-2.
VIII. Conclusions
The Sangria™ Thrombectomy System has been carefully compared to the legally marketed predicate device with respect to indications for use, technological characteristics, performance, and safety characteristics. Non-clinical testing was conducted to validate the performance of the devices and ensure the Sangria™ Thrombectomy System functions as intended and meet design specifications. The comparison and non-clinical results demonstrate that the Sangria™ Thrombectomy System is substantially equivalent to the predicate device for its intended use.
Page 5 of 5
§ 870.5150 Embolectomy catheter.
(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).