Bactiseal EVD Catheter Sets; Bactiseal Clear EVD Catheter Set— 510(k) K233448
Substantially EquivalentIntegra Lifesciences Production Corporation
FDA 510(k) clearance K233448 for Bactiseal EVD Catheter Sets; Bactiseal Clear EVD Catheter Set, Substantially Equivalent on 2023-12-19. 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)
- K233445 — Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bactiseal Endoscopic Ventricular Catheter
- 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 →
Recalls naming K233448
K-number listed on FDA's recall record- Z-2136-2024 — CODMAN BACTISEAL EVD Catheter Set - Indicated for gaining access to the ventricles of the brain and can be used with dimensionally compatible devices for draining cerebrospinal fluid (CSF) and other fluids of similar physical characteristics as a means of reducing intracranial pressure and CSF volume. Product Number: 821745
- Z-2137-2024 — CODMAN EVD BACTISEAL 1.9mm I.D. Catheter Set- indicated for gaining access to the ventricles of the brain and can be used with dimensionally compatible devices for draining cerebrospinal fluid (CSF) and other fluids of similar physical characteristics as a means of reducing intracranial pressure and CSF volume. Product Number: 821749
- Z-2138-2024 — CODMAN BACTISEAL Clear EVD Catheter 1.9mm I.D. Catheter Set- indicated for gaining access to the ventricles of the brain and can be used with dimensionally compatible devices for draining cerebrospinal fluid (CSF) and other fluids of similar physical characteristics as a means of reducing intracranial pressure and CSF volume. Product Number: 821750
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K233448.
Data sourced from openFDA. This site is unofficial and independent of the FDA.