The following data is part of a premarket notification filed by Medtronic Inc. Cardiac Rhythm Management with the FDA for Medtronic Selectsite Deflectable Catheter System, Models C304-s59 And C304-l69.
| Device ID | K033989 |
| 510k Number | K033989 |
| Device Name: | MEDTRONIC SELECTSITE DEFLECTABLE CATHETER SYSTEM, MODELS C304-S59 AND C304-L69 |
| Classification | Catheter, Percutaneous |
| Applicant | MEDTRONIC INC. CARDIAC RHYTHM MANAGEMENT 7000 CENTRAL AVE. N.E. Minneapolis, MN 55432 |
| Contact | Kristy K Mollner |
| Correspondent | Kristy K Mollner MEDTRONIC INC. CARDIAC RHYTHM MANAGEMENT 7000 CENTRAL AVE. N.E. Minneapolis, MN 55432 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-12-23 |
| Decision Date | 2004-01-22 |
| Summary: | summary |