The following data is part of a premarket notification filed by Cordis Corporation with the FDA for Adroit Guiding Catheter.
| Device ID | K143412 |
| 510k Number | K143412 |
| Device Name: | ADROIT Guiding Catheter |
| Classification | Catheter, Percutaneous |
| Applicant | CORDIS CORPORATION 6500 PASEO PADRE PKWY Fremont, CA 94555 |
| Contact | Babu Periasamy |
| Correspondent | Babu Periasamy CORDIS CORPORATION 6500 PASEO PADRE PKWY Fremont, CA 94555 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-11-28 |
| Decision Date | 2015-01-14 |
| Summary: | summary |