BD SINGLE LUMEN NEEDLE, SYRINGE AND BLOOD COLLECTION SET
FDA 510(k) clearance K021475 · decided 2002-07-19
Clearance details
- K-number
- K021475
- Device name
- BD SINGLE LUMEN NEEDLE, SYRINGE AND BLOOD COLLECTION SET
- Applicant
- Bd
- Decision
- Substantially Equivalent
- Date received
- 2002-05-08
- Decision date
- 2002-07-19
- Days to decision
- 72 days
- Clearance type
- Traditional
- Product code
- FMI
- Device class
- 2
- Regulation number
- 880.5570
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Franklin Lakes, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| BD 30G1/2" Precision Glide" Needle Needles are used for aspiration and injection of medica recall (Z-1009-2012) | Becton Dickinson & Company | 2012-02-13 |