LOW PROFILE LUTHER SAFETY HUBER
FDA 510(k) clearance K040527 · decided 2004-03-26
Clearance details
- K-number
- K040527
- Device name
- LOW PROFILE LUTHER SAFETY HUBER
- Applicant
- Luther Needlesafe Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-03-01
- Decision date
- 2004-03-26
- Days to decision
- 25 days
- Clearance type
- Special
- Product code
- FPA
- Device class
- 2
- Regulation number
- 880.5440
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| SafeStep Huber Needle Set with Y-Injection Site. Product Code: LH-0029YN. Packaged as sing recall (Z-0986-2017) | Bard Access Systems | 2017-01-10 |
| BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: SafeStep Po recall (Z-1273-2015) | Bard Access Systems | 2015-03-13 |