ERIC Retrieval Device
FDA 510(k) K211120 · MicroVention, Inc.
510(k) numberK211120
Submission
- Device name
- ERIC Retrieval Device
- Applicant
- MicroVention, Inc.
Aliso Viejo, CA, US - Received
- April 15, 2021
- Decision date
- March 31, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NRY – Catheter, Thrombus Retriever
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1250
- Specialty
- Cardiovascular
The device is intended to restore blood flow by removing thrombus/clots in patients experiencing ischemic stroke. The prior clearances in this category have been limited to simply identifying catheter placed in the peripheral, coronary, and neurovasculature. It is felt that this is a unique claim and should not be combined with previously cleared catheters under a general procode.
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| K223050 | AZUR HydroPack 18 (45-880005; 45-880010; 45-880020; 45-880035; 45-880050; 45-880060)KRD · Traditional | 12/21/2022SE |
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| K201487 | Traxcess 7 Mini GuidewireMOF · Special | 07/02/2020SE |
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Questions and answers
When was ERIC Retrieval Device cleared by the FDA?
ERIC Retrieval Device (K211120) received a 510(k) decision of Substantially Equivalent on March 31, 2022, 350 days after the submission was received.
What is the product code of K211120?
The FDA product code is NRY – Catheter, Thrombus Retriever, a Class II (moderate risk) device regulated under 21 CFR 870.1250.