The following data is part of a premarket notification filed by Medtronic, Inc. with the FDA for Exacta External Drainage And Monitoring System, Exacta Pole With Laser Level, Exacta System Replacement Drainage Bag, Replacement Laser Level.
| Device ID | K201118 |
| 510k Number | K201118 |
| Device Name: | Exacta External Drainage And Monitoring System, Exacta Pole With Laser Level, Exacta System Replacement Drainage Bag, Replacement Laser Level |
| Classification | Device, Monitoring, Intracranial Pressure |
| Applicant | Medtronic, Inc. 5290 California Ave Irvine, CA 92617 |
| Contact | Jen Correa |
| Correspondent | Jen Correa Medtronic, Inc. 5290 California Ave Irvine, CA 92617 |
| Product Code | GWM |
| CFR Regulation Number | 882.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-04-27 |
| Decision Date | 2020-05-26 |