Medtronic PS Medical Strata Valve
FDA 510(k) K040943 · Medtronic Neurosurgery
510(k) numberK040943
Submission
- Device name
- Medtronic PS Medical Strata Valve
- Applicant
- Medtronic Neurosurgery
Goleta, CA, US - Received
- April 12, 2004
- Decision date
- June 15, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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More from Aesculap, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K243676 | Duet External Drainage and Monitoring System (EDMS)JXG · Traditional | 03/10/2025SE |
| K242034 | Duet External Drainage and Monitoring System (EDMS)PCB · Special | 10/24/2024SE |
| K212641 | StrataMR II Valves and ShuntsJXG · Special | 09/16/2021SE |
| K181622 | StrataMR guider toolJXG · Traditional | 10/01/2018SE |
| K161370 | Durepair Dura Regeneration MatrixGXQ · Traditional | 11/02/2016SE |
| K152700 | StrataMR Valves and ShuntsJXG · Traditional | 04/07/2016SE |
| K123524 | Medtronic Strata NSC Lumboperitoneal Valve and Shunt SystemJXG · Traditional | 02/13/2013SE |
| K110560 | Medtronic Ares Antibiotic-Impregnated CatheterJXG · Traditional | 11/18/2011SE |
| K091312 | PS Medical Strata NSC Lumboperitoneal Valve and Shunt SystemJXG · Traditional | 09/02/2009SE |
| K083076 | Strata Burr Hole Valve, Model 42836 and Strata Burr Hole Shunt Assembly, Model 46836JXG · Special | 11/20/2008SE |
Questions and answers
When was Medtronic PS Medical Strata Valve cleared by the FDA?
Medtronic PS Medical Strata Valve (K040943) received a 510(k) decision of Substantially Equivalent on June 15, 2004, 64 days after the submission was received.
What is the product code of K040943?
The FDA product code is JXG – Shunt, Central Nervous System And Components, a Class II (moderate risk) device regulated under 21 CFR 882.5550.