The following data is part of a premarket notification filed by Codman & Shurtleff, Inc. with the FDA for Yoga Microcatheter, 0.032, 150cm, Back Up And Extra Back Up.
| Device ID | K171653 |
| 510k Number | K171653 |
| Device Name: | YOGA Microcatheter, 0.032, 150cm, Back Up And Extra Back Up |
| 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 | 2017-06-05 |
| Decision Date | 2017-07-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10886704081296 | K171653 | 000 |
| 10886704081289 | K171653 | 000 |
| 10886704079903 | K171653 | 000 |
| 10886704079415 | K171653 | 000 |
| 10886704079262 | K171653 | 000 |
| 10886704079255 | K171653 | 000 |
| 10886704079248 | K171653 | 000 |