The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for 10600 Deflectable Catheter System, Model 10600.
| Device ID | K013517 |
| 510k Number | K013517 |
| Device Name: | 10600 DEFLECTABLE CATHETER SYSTEM, MODEL 10600 |
| Classification | Catheter, Percutaneous |
| Applicant | MEDTRONIC VASCULAR 7000 CENTRAL AVE. N.E. Minneapolis, MN 55432 |
| Contact | Kristy K Mollner |
| Correspondent | Kristy K Mollner MEDTRONIC VASCULAR 7000 CENTRAL AVE. N.E. Minneapolis, MN 55432 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-10-22 |
| Decision Date | 2002-04-25 |
| Summary: | summary |