MILLENNIUM HUBER PLUS SAFETY INFUSION SET
FDA 510(k) clearance K993848 · decided 2000-01-27
Clearance details
- K-number
- K993848
- Device name
- MILLENNIUM HUBER PLUS SAFETY INFUSION SET
- Applicant
- Millennium Medical Distribution, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1999-11-12
- Decision date
- 2000-01-27
- Days to decision
- 76 days
- Clearance type
- Traditional
- Product code
- FPA
- Device class
- 2
- Regulation number
- 880.5440
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Santa Barbara, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Huber Plus Non-Coring Needle Safety Infusion Set, 19g, 1 inch, Needless Y-site, REF 011901 recall (Z-0861-2010) | Bard Access Systems | 2010-02-26 |
| Huber Plus Non-Coring Needle Safety Infusion Set, 19g, 1 inch, REF 011901, Sterile EO, Ass recall (Z-0862-2010) | Bard Access Systems | 2010-02-26 |