The following data is part of a premarket notification filed by Medtronic Inc. with the FDA for Medtronic Vascular - Hub Material Modification To The 5f And 8f Launcher(r) Guide Catheters.
| Device ID | K103386 |
| 510k Number | K103386 |
| Device Name: | MEDTRONIC VASCULAR - HUB MATERIAL MODIFICATION TO THE 5F AND 8F LAUNCHER(R) GUIDE CATHETERS |
| Classification | Catheter, Percutaneous |
| Applicant | MEDTRONIC INC. 35-37A CHERRY HILL DRIVE Danvers, MA 01923 -5186 |
| Contact | Anu Gaur |
| Correspondent | Anu Gaur MEDTRONIC INC. 35-37A CHERRY HILL DRIVE Danvers, MA 01923 -5186 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-11-18 |
| Decision Date | 2011-02-11 |
| Summary: | summary |