Guarded Luer Connector
FDA 510(k) clearance K173577 · decided 2018-06-07
Clearance details
- K-number
- K173577
- Device name
- Guarded Luer Connector
- Applicant
- International Medical Industries, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2017-11-20
- Decision date
- 2018-06-07
- Days to decision
- 199 days
- Clearance type
- Traditional
- Product code
- LHI
- Device class
- 2
- Regulation number
- 880.5440
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Pompano Beach, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Prep-Fill Guarded Luer Connector (GLC): a. Part Number 57-400, Female Lock - Female Lock G recall (Z-0925-2023) | International Medical Industries, Inc. | 2023-01-07 |