The following data is part of a premarket notification filed by St. Jude Medical, Cardiac Rhythm Management Divisi with the FDA for Cps Direct Mediguide Enabled Outer Catheter.
| Device ID | K120296 |
| 510k Number | K120296 |
| Device Name: | CPS DIRECT MEDIGUIDE ENABLED OUTER CATHETER |
| Classification | Catheter, Percutaneous |
| Applicant | ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI 15900 VALLEY VIEW CT. Sylmar, CA 91342 |
| Contact | Colleen Canan |
| Correspondent | Colleen Canan ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI 15900 VALLEY VIEW CT. 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 | 2012-01-31 |
| Decision Date | 2012-05-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05415067003799 | K120296 | 000 |
| 05415067003782 | K120296 | 000 |
| 05415067003775 | K120296 | 000 |