The following data is part of a premarket notification filed by Clarus Medical, Llc with the FDA for Clarus Peel-away Introducer Sheath.
| Device ID | K200925 |
| 510k Number | K200925 |
| Device Name: | Clarus Peel-Away Introducer Sheath |
| Classification | Endoscope, Neurological |
| Applicant | Clarus Medical, LLC 13355 10th Ave N Suite 110 Plymouth, MN 55441 |
| Contact | Mark F. Brown |
| Correspondent | Mark F. Brown Clarus Medical, LLC 13355 10th Ave N Suite 110 Plymouth, MN 55441 |
| Product Code | GWG |
| CFR Regulation Number | 882.1480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-04-07 |
| Decision Date | 2021-03-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810004820746 | K200925 | 000 |