ZelanteDVT THrombectomy System, ZelanteDVT ClotHunter Helical Rotation Device
FDA 510(k) K202218 · Boston Scientific Corporation
510(k) numberK202218
Submission
- Device name
- ZelanteDVT THrombectomy System, ZelanteDVT ClotHunter Helical Rotation Device
- Applicant
- Boston Scientific Corporation
Maple Grove, MN, US - Received
- August 6, 2020
- Decision date
- October 2, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QEW – Peripheral Mechanical Thrombectomy With Aspiration
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.5150
- Specialty
- Cardiovascular
To mechanically disrupt thrombus and/or debris prior to removal from the peripheral vasculature through aspiration.
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| K261800 | Helo Max Thrombectomy System (HEL2090)QEW · Traditional | Endovascular Engineering | 09/03/2026SE |
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| K261523 | Vertex Thrombectomy SystemQEW · Traditional | Jupiter Endovascular | 08/04/2026SE |
| K260599 | INDIGO® Aspiration System INDIGO LinkQEW · Traditional | Penumbra, Inc. | 04/24/2026SE |
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| K251949 | INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINKQEW · Traditional | Penumbra, Inc. | 02/05/2026SE |
| K253730 | RoVo Mechanical Thrombectomy SystemQEW · Special | Verge Medical, Inc. | 01/21/2026SE |
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| K252956 | Helo Thrombectomy SystemQEW · Traditional | Endovascular Engineering, Inc. | 12/18/2025SE |
| K251070 | Akura Thrombectomy SystemQEW · Traditional | Akura Medical | 11/25/2025SE |
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Questions and answers
When was ZelanteDVT THrombectomy System, ZelanteDVT ClotHunter Helical Rotation Device cleared by the FDA?
ZelanteDVT THrombectomy System, ZelanteDVT ClotHunter Helical Rotation Device (K202218) received a 510(k) decision of Substantially Equivalent on October 2, 2020, 57 days after the submission was received.
What is the product code of K202218?
The FDA product code is QEW – Peripheral Mechanical Thrombectomy With Aspiration, a Class II (moderate risk) device regulated under 21 CFR 870.5150.