The following data is part of a premarket notification filed by Codman & Shurtleff, Inc. with the FDA for Yoga Microcatheter.
| Device ID | K162563 |
| 510k Number | K162563 |
| Device Name: | YOGA Microcatheter |
| Classification | Catheter, Percutaneous |
| Applicant | CODMAN & SHURTLEFF, INC. 325 PARAMOUNT DRIVE Raynham, MA 02767 |
| Contact | Yoon Hee Beatty |
| Correspondent | Yoon Hee Beatty CODMAN & SHURTLEFF, INC. 325 PARAMOUNT DRIVE Raynham, MA 02767 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-14 |
| Decision Date | 2017-01-05 |
| Summary: | summary |