The following data is part of a premarket notification filed by St. Jude Medical with the FDA for Luminary Cannulator Bideflectable Catheter With Lumen.
| Device ID | K052575 |
| 510k Number | K052575 |
| Device Name: | LUMINARY CANNULATOR BIDEFLECTABLE CATHETER WITH LUMEN |
| Classification | Catheter, Steerable |
| Applicant | ST. JUDE MEDICAL 14901 DEVEAU PL. Minnetonka, MN 55345 -2126 |
| Contact | Patrice Stromberg |
| Correspondent | Patrice Stromberg ST. JUDE MEDICAL 14901 DEVEAU PL. Minnetonka, MN 55345 -2126 |
| Product Code | DRA |
| CFR Regulation Number | 870.1280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-19 |
| Decision Date | 2006-01-19 |
| Summary: | summary |