510(k) K023368
K023368 is an FDA 510(k) premarket notification submitted by Aortech Critical Care , Ltd. for the device "TRUCATH.IP". The FDA issued a decision of Substantially Equivalent on October 28, 2002. The device falls under product code DFG (Lambda, Rhodamine, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5550.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 28, 2002
- Date Received
- October 8, 2002
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Lambda, Rhodamine, Antigen, Antiserum, Control
- Device Class
- Class II
- Regulation Number
- 866.5550
- Review Panel
- IM
- Submission Type