The following data is part of a premarket notification filed by St. Jude Medical with the FDA for Cps Direct Mediguide Enabled Outer Catheter.
| Device ID | K142239 |
| 510k Number | K142239 |
| Device Name: | CPS Direct MediGuide Enabled Outer Catheter |
| Classification | Catheter, Percutaneous |
| Applicant | St. Jude Medical 15900 Valley View Court Sylmar, CA 91342 |
| Contact | Geena George |
| 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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05414734509497 | K142239 | 000 |
| 05414734509480 | K142239 | 000 |
| 05414734509473 | K142239 | 000 |
| 05414734509466 | K142239 | 000 |