Hakim Programmable Valves, Hakim Precision Fixed Pressure Valves— 510(k) K221840
Substantially EquivalentIntegra Lifesciences Production Corporation
FDA 510(k) clearance K221840 for Hakim Programmable Valves, Hakim Precision Fixed Pressure Valves, Substantially Equivalent on 2022-10-14. 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
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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
- K233448 — Bactiseal EVD Catheter Sets; Bactiseal Clear EVD Catheter Set
- K223330 — Certas Plus Programmable 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.