K242034 is an FDA 510(k) clearance for the Duet External Drainage and Monitoring System (EDMS). This device is classified as a External Cerebrospinal Fluid (csf) Diversion (Class II - Special Controls, product code PCB).
Submitted by Medtronic Neurosurgery (Fort Worth, US). The FDA issued a Cleared decision on October 24, 2024, 105 days after receiving the submission on July 11, 2024.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5560. Cerebrospinal Fluid (csf) Diversion Intended To Alter Spinal Cord Perfusion..
| 510(k) Number | K242034 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 11, 2024 |
| Decision Date | October 24, 2024 |
| Days to Decision | 105 days |
| Submission Type | Special |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | PCB — External Cerebrospinal Fluid (csf) Diversion |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5560 |
| Definition | Cerebrospinal Fluid (csf) Diversion Intended To Alter Spinal Cord Perfusion. |