The following data is part of a premarket notification filed by St. Jude Medical with the FDA for Cps Excel Mediguide Enabled Guidewire, Cps Excel Mediguide Torque Clip, Cps Excel Mediguide Guidewire Connector.
| Device ID | K142254 |
| 510k Number | K142254 |
| Device Name: | CPS Excel MediGuide Enabled Guidewire, CPS Excel MediGuide Torque Clip, CPS Excel MediGuide Guidewire Connector |
| Classification | Wire, Guide, Catheter |
| 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 | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-14 |
| Decision Date | 2014-11-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05415067003850 | K142254 | 000 |
| 05414734509459 | K142254 | 000 |
| 05414734505352 | K142254 | 000 |
| 05414734505345 | K142254 | 000 |
| 05414734505338 | K142254 | 000 |