The following data is part of a premarket notification filed by Medtronic, Inc. with the FDA for Export Advance Aspiration Catheter.
| Device ID | K152335 |
| 510k Number | K152335 |
| Device Name: | Export Advance Aspiration Catheter |
| Classification | Catheter, Embolectomy |
| Applicant | Medtronic, Inc. 37A Cherry Hill Drive Danvers, MA 01923 |
| Contact | Colleen Mullins |
| Correspondent | Colleen Mullins Medtronic, Inc. 37A Cherry Hill Drive Danvers, MA 01923 |
| Product Code | DXE |
| CFR Regulation Number | 870.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-19 |
| Decision Date | 2015-09-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169647343 | K152335 | 000 |