TRUCATH.IP
FDA 510(k) clearance K023368 · decided 2002-10-28
Clearance details
- K-number
- K023368
- Device name
- TRUCATH.IP
- Applicant
- Aortech Critical Care , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2002-10-08
- Decision date
- 2002-10-28
- Days to decision
- 20 days
- Clearance type
- Traditional
- Product code
- DFG
- Device class
- 2
- Regulation number
- 866.5550
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Bellshill, Lanarkshire, GB
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.