WIRION Embolic Protection System
FDA 510(k) K210282 · Cardiovascular Systems, Inc.
510(k) numberK210282
Submission
- Device name
- WIRION Embolic Protection System
- Applicant
- Cardiovascular Systems, Inc.
St.Paul, MN, US - Received
- February 1, 2021
- Decision date
- March 3, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NTE – Temporary Carotid Catheter For Embolic Capture
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1250
- Specialty
- Cardiovascular
This device is a single use percutaneous catheter system that is introduced into an artery through the skin using a guidewire. The catheter has an embolic capture filter or an occlusion balloon at the distal end. The filter or balloon can be placed either distally to the lesion or proximally depending on the design of the device and intended use. The filter or balloon is used to capture embolic…
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| K200198 | WirionNTE · Traditional | Cardiovascular Systems, Inc. | 03/18/2020SE |
| K191173 | Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery WiresNTE · Traditional | Abbott Vascular | 07/25/2019SE |
| K180023 | WirionNTE · Traditional | Gardia Medical , Ltd. | 03/21/2018SE |
| K153485 | ENROUTE Transcarotid Neuroprotection SystemNTE · Traditional | Silk Road Medical, Inc. | 03/10/2016SE |
| K153086 | RX ACCUNET Embolic Protection SystemNTE · Special | Abbott Vascular | 11/20/2015SE |
| K143570 | WirionNTE · Traditional | Gardia Medical | 06/04/2015SE |
| K143072 | ENROUTE Transcarotid Neuroprotection SystemNTE · Traditional | Silk Road Medical, Inc. | 02/09/2015SE |
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Questions and answers
When was WIRION Embolic Protection System cleared by the FDA?
WIRION Embolic Protection System (K210282) received a 510(k) decision of Substantially Equivalent on March 3, 2021, 30 days after the submission was received.
What is the product code of K210282?
The FDA product code is NTE – Temporary Carotid Catheter For Embolic Capture, a Class II (moderate risk) device regulated under 21 CFR 870.1250.