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 |