TEXIUM SYRINGE
FDA 510(k) clearance K071108 · decided 2007-05-24
Clearance details
- K-number
- K071108
- Device name
- TEXIUM SYRINGE
- Applicant
- Cardinal Health, Alaris Products
- Decision
- Substantially Equivalent
- Date received
- 2007-04-19
- Decision date
- 2007-05-24
- Days to decision
- 35 days
- Clearance type
- Traditional
- Product code
- FMF
- Device class
- 2
- Regulation number
- 880.5860
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| BD Texium Needle-Free Syringe: 3 mL, REF: MY8003; 5 mL, REF: MY8005; 10 mL, REF: MY8010; 2 recall (Z-1971-2025) | BD SWITZERLAND SARL | 2025-06-12 |