510(k) K200456 ยท GWM Device, Monitoring, Intracranial Pressure
Becker External Drainage and Monitoring System
| Applicant | Medtronic, Inc., Goleta CA, US |
| Decision | Substantially Equivalent, Mar 26, 2020 |
| Received | Feb 25, 2020 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K200456
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 19, 2024 | Medtronic Neurosurgery Becker External Drainage and Monitoring System:
24146 EDMS 24146 BECKER NO Y-SITE
25120 EDMS II 25120 BECKER W/1-WAY VALVE
26040 KIT 26040 BECKER EDMS II
27609 BECKER 27609 W/NEEDLESLESS INJ. SITE
276 Open, Classified |
GWM | None listed |
| Dec 19, 2024 | Medtronic Neurosurgery Exacta External Drainage and Monitoring System:
27581 KIT 27581 EXACTA W/EDM VCATH 35CM
27636 EDM 27636 EXACTA W/BRAIDED CORD LOCK
27666 EDM 27666 EXCTA W GLUE STPCK GR PT LN
27732 EDM 27732 EXACTA W/ Open, Classified |
GWM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.