The following data is part of a premarket notification filed by Medtronic Inc. with the FDA for Export Xt Catheter, Export Ap Catheter.
| Device ID | K120808 |
| 510k Number | K120808 |
| Device Name: | EXPORT XT CATHETER, EXPORT AP CATHETER |
| Classification | Catheter, Embolectomy |
| 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 | DXE |
| CFR Regulation Number | 870.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-03-16 |
| Decision Date | 2012-06-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994431745 | K120808 | 000 |