The following data is part of a premarket notification filed by St. Jude Medical with the FDA for Cps Direct Pl Peelable Outer Guide Catheter; Accessory, Valve Bypass Tools.
| Device ID | K061710 |
| 510k Number | K061710 |
| Device Name: | CPS DIRECT PL PEELABLE OUTER GUIDE CATHETER; ACCESSORY, VALVE BYPASS TOOLS |
| Classification | Catheter, Percutaneous |
| Applicant | ST. JUDE MEDICAL 15900 VALLEY VIEW CT. Sylmar, CA 91342 -3577 |
| Contact | Adele Shoustal |
| Correspondent | Adele Shoustal ST. JUDE MEDICAL 15900 VALLEY VIEW CT. Sylmar, CA 91342 -3577 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-06-19 |
| Decision Date | 2006-07-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05414734207218 | K061710 | 000 |
| 05414734206938 | K061710 | 000 |
| 05414734206921 | K061710 | 000 |
| 05414734206914 | K061710 | 000 |
| 05414734206907 | K061710 | 000 |
| 05414734206891 | K061710 | 000 |
| 05414734206884 | K061710 | 000 |
| 05414734206877 | K061710 | 000 |
| 05414734206860 | K061710 | 000 |
| 05414734206853 | K061710 | 000 |
| 05414734206846 | K061710 | 000 |
| 05414734206839 | K061710 | 000 |
| 05414734206822 | K061710 | 000 |
| 05414734206815 | K061710 | 000 |
| 05414734206808 | K061710 | 000 |
| 05414734206792 | K061710 | 000 |
| 05414734207041 | K061710 | 000 |
| 05414734207058 | K061710 | 000 |
| 05414734207201 | K061710 | 000 |
| 05414734207195 | K061710 | 000 |
| 05414734207188 | K061710 | 000 |
| 05414734207171 | K061710 | 000 |
| 05414734207164 | K061710 | 000 |
| 05414734207157 | K061710 | 000 |
| 05414734207140 | K061710 | 000 |
| 05414734207133 | K061710 | 000 |
| 05414734207126 | K061710 | 000 |
| 05414734207119 | K061710 | 000 |
| 05414734207102 | K061710 | 000 |
| 05414734207096 | K061710 | 000 |
| 05414734207089 | K061710 | 000 |
| 05414734207072 | K061710 | 000 |
| 05414734207065 | K061710 | 000 |
| 05414734206785 | K061710 | 000 |