VACUETTE SAFELINK Holder with male luer lock
FDA 510(k) clearance K180545 · decided 2018-05-21
Clearance details
- K-number
- K180545
- Device name
- VACUETTE SAFELINK Holder with male luer lock
- Applicant
- Greiner Bio-One Na, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2018-03-01
- Decision date
- 2018-05-21
- Days to decision
- 81 days
- Clearance type
- Traditional
- Product code
- FMI
- Device class
- 2
- Regulation number
- 880.5570
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Monroe, NC, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| VACUETTE SAFELINK, REF: 450210 recall (Z-0802-2025) | Greiner Bio-One GmbH | 2025-01-03 |