Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bactiseal Endoscopic Ventricular Catheter— 510(k) K233445
Substantially EquivalentIntegra Lifesciences Production Corporation
FDA 510(k) clearance K233445 for Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bactiseal Endoscopic Ventricular Catheter, Substantially Equivalent on 2024-01-17. Applicant: Integra Lifesciences Production Corporation. Device class: 2.
Clearance details
- Applicant
- Integra Lifesciences Production Corporation
- 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
- Mansfield, MA, US
Recent devices under product code JXG
view allMore clearances from Integra Lifesciences Production Corporation
view all- K243552 — Codman Libertís 1.5 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection (821761) +1 more
- K232890 — CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845)
- K233448 — Bactiseal EVD Catheter Sets; Bactiseal Clear EVD Catheter Set
- K223330 — Certas Plus Programmable Valves
- K221840 — Hakim Programmable Valves, Hakim Precision Fixed Pressure Valves
Adverse 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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.