The following data is part of a premarket notification filed by Cardiovascular Systems Inc. with the FDA for Wirion Embolic Protection System.
| Device ID | K210282 |
| 510k Number | K210282 |
| Device Name: | WIRION Embolic Protection System |
| Classification | Temporary Carotid Catheter For Embolic Capture |
| Applicant | Cardiovascular Systems Inc. 1225 Old Hwy 8 NW St. Paul, MN 55112 |
| Contact | Erika Huffman |
| Correspondent | Erika Huffman Cardiovascular Systems Inc. 1225 Old Hwy 8 NW St. Paul, MN 55112 |
| Product Code | NTE |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-02-01 |
| Decision Date | 2021-03-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10850000491882 | K210282 | 000 |