The following data is part of a premarket notification filed by St. Jude Medical with the FDA for Cps Aim Mediguide Enabled Inner Catheter, Cps Aim Mediguide Enabled Inner Catheter.
| Device ID | K142235 |
| 510k Number | K142235 |
| Device Name: | CPS Aim MediGuide Enabled Inner Catheter, CPS Aim Mediguide Enabled Inner Catheter |
| Classification | Catheter, Percutaneous |
| Applicant | St. Jude Medical 15900 Valley View Court Sylmar, CA 91342 |
| Contact | Zachary Price |
| Correspondent | Zachary Price St. Jude Medical 15900 Valley View Court Sylmar, CA 91342 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-13 |
| Decision Date | 2014-12-18 |
| Summary: | summary |