SMARTPORT CT MP PORT ACCESS SYSTEM AND LIFEGUARD CT SAFETY INFUSION SET
FDA 510(k) clearance K072375 · decided 2007-12-13
Clearance details
- K-number
- K072375
- Device name
- SMARTPORT CT MP PORT ACCESS SYSTEM AND LIFEGUARD CT SAFETY INFUSION SET
- Applicant
- AngioDynamics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-08-23
- Decision date
- 2007-12-13
- Days to decision
- 112 days
- Clearance type
- Traditional
- Product code
- FPA
- Device class
- 2
- Regulation number
- 880.5440
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Queensburgy, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.