LIFEGUARD SAFETY INFUSION SET
FDA 510(k) clearance K013871 · decided 2002-03-29
Clearance details
- K-number
- K013871
- Device name
- LIFEGUARD SAFETY INFUSION SET
- Applicant
- Horizon Medical Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-11-21
- Decision date
- 2002-03-29
- Days to decision
- 128 days
- Clearance type
- Traditional
- Product code
- FPA
- Device class
- 2
- Regulation number
- 880.5440
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Manchester, GA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Lifeguard Infusion Set with Smartsite, 20Ga, 1, CLGY-2010 Huber type needle set used for t recall (Z-0914-2013) | Churchill Medical Systems, Inc. | 2013-03-06 |
| Churchill Medical Systems LifeGuard Non-Coring Huber Needle, Lifeguard Non-Coring Safety I recall (Z-1327-2011) | Churchill Medical Systems, Inc. | 2011-02-16 |