The following data is part of a premarket notification filed by Clearmind Biomedical with the FDA for Clearpath Disposable Introducer.
| Device ID | K210251 |
| 510k Number | K210251 |
| Device Name: | ClearPath Disposable Introducer |
| Classification | Endoscope, Neurological |
| Applicant | ClearMind Biomedical 5F, No. 167, Fuxing N. Rd., Songshan Dist. Taipei, TW 105403 |
| Contact | Sheng-chi (aka Vance Lin) Lin |
| Correspondent | Craig Coombs Coombs Medical Device Consulting, Inc. 1100 Pacific Marina, Suite 806 Alameda, CA 94501 |
| Product Code | GWG |
| CFR Regulation Number | 882.1480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-01-29 |
| Decision Date | 2021-04-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860000321341 | K210251 | 000 |