The following data is part of a premarket notification filed by Cordis Corp., A Johnson & Johnson Co. with the FDA for Adroit Guiding Catheter.
| Device ID | K131225 |
| 510k Number | K131225 |
| Device Name: | ADROIT GUIDING CATHETER |
| Classification | Catheter, Percutaneous |
| Applicant | CORDIS CORP., A JOHNSON & JOHNSON CO. 6500 PASEO PADRE PKWY. Fremont, CA 94555 |
| Contact | Mary E Holden |
| Correspondent | Mary E Holden CORDIS CORP., A JOHNSON & JOHNSON CO. 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 | 2013-04-30 |
| Decision Date | 2013-05-29 |