Bactiseal EVD Catheter Sets; Bactiseal Clear EVD Catheter Set
FDA 510(k) clearance K233448 · decided 2023-12-19
Clearance details
- K-number
- K233448
- Device name
- Bactiseal EVD Catheter Sets; Bactiseal Clear EVD Catheter Set
- Applicant
- Integra Lifesciences Production Corporation
- Decision
- Substantially Equivalent
- Date received
- 2023-10-20
- Decision date
- 2023-12-19
- Days to decision
- 60 days
- Clearance type
- Traditional
- Product code
- JXG
- Device class
- 2
- Regulation number
- 882.5550
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Mansfield, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| CODMAN BACTISEAL EVD Catheter Set - Indicated for gaining access to the ventricles of the recall (Z-2136-2024) | Integra LifeSciences Corp. | 2024-06-12 |
| CODMAN EVD BACTISEAL 1.9mm I.D. Catheter Set- indicated for gaining access to the ventricl recall (Z-2137-2024) | Integra LifeSciences Corp. | 2024-06-12 |
| CODMAN BACTISEAL Clear EVD Catheter 1.9mm I.D. Catheter Set- indicated for gaining access recall (Z-2138-2024) | Integra LifeSciences Corp. | 2024-06-12 |