MEDTRONIC ARES ANTIBIOTIC-IMPREGNATED CATHETER— 510(k) K110560
Substantially EquivalentMedtronic Neurosurgery
FDA 510(k) clearance K110560 for MEDTRONIC ARES ANTIBIOTIC-IMPREGNATED CATHETER, Substantially Equivalent on 2011-11-18. Applicant: Medtronic Neurosurgery. Device class: 2.
Clearance details
- Applicant
- Medtronic Neurosurgery
- Product code
- Code JXG
- Device class
- Class 2
- Regulation
- 21 CFR 882.5550
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Goleta, CA, US
Recent devices under product code JXG
view allMore clearances from Medtronic Neurosurgery
view allAdverse events under product code JXG
product code JXG- Death
- 76
- Injury
- 5,632
- Malfunction
- 2,230
- Other
- 4
- Total
- 7,942
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K110560
K-number listed on FDA's recall record- Z-0738-2021 — Medtronic Ares Antibiotic-Impregnated Catheter, REF: 91101, Sterile, Rx Only. Used in the treatment of hydrocephalus as a component of a shunt system when draining or shunting of cerebrospinal fluid (CSF) is indicated.
- Z-0739-2021 — Medtronic Ares Antibiotic-Impregnated Catheter, REF: 93092, Sterile, Rx Only. Used in the treatment of hydrocephalus as a component of a shunt system when draining or shunting of cerebrospinal fluid (CSF) is indicated.
- Z-0740-2021 — Medtronic Ares Antibiotic-Impregnated Catheter, REF: 95001, Sterile, Rx Only. Used in the treatment of hydrocephalus as a component of a shunt system when draining or shunting of cerebrospinal fluid (CSF) is indicated.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K110560.
Data sourced from openFDA. This site is unofficial and independent of the FDA.