Medtronic Ares Antibiotic-Impregnated Catheter
FDA 510(k) K110560 · Medtronic Neurosurgery
510(k) numberK110560
Submission
- Device name
- Medtronic Ares Antibiotic-Impregnated Catheter
- Applicant
- Medtronic Neurosurgery
Goleta, CA, US - Received
- February 28, 2011
- Decision date
- November 18, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| 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 |
| 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 |
| K082127 | Strata NSC Burr Hole Valve, Model 42335; Shunt Assembly, Model 46635JXG · Special | 08/27/2008SE |
Questions and answers
When was Medtronic Ares Antibiotic-Impregnated Catheter cleared by the FDA?
Medtronic Ares Antibiotic-Impregnated Catheter (K110560) received a 510(k) decision of Substantially Equivalent on November 18, 2011, 263 days after the submission was received.
What is the product code of K110560?
The FDA product code is JXG – Shunt, Central Nervous System And Components, a Class II (moderate risk) device regulated under 21 CFR 882.5550.