The following data is part of a premarket notification filed by Microvention Inc. with the FDA for Eric Retrieval Device.
Device ID | K211120 |
510k Number | K211120 |
Device Name: | ERIC Retrieval Device |
Classification | Catheter, Thrombus Retriever |
Applicant | MicroVention Inc. 35 Enterprise Aliso Viejo, CA 92656 |
Contact | Stephanie Onstot |
Correspondent | Sapna Singh MicroVention Inc. 35 Enterprise Aliso Viejo, CA 92656 |
Product Code | NRY |
CFR Regulation Number | 870.1250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-04-15 |
Decision Date | 2022-03-31 |