510(k) K112323
K112323 is an FDA 510(k) premarket notification submitted by Millar Instruments, Inc. for the device "CARDIA-CATH". The FDA issued a decision of Substantially Equivalent on October 18, 2011. The device falls under product code DXO (Transducer, Pressure, Catheter Tip), a Class II device regulated under 21 CFR 870.2870. Millar Instruments, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 18, 2011
- Date Received
- August 12, 2011
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Transducer, Pressure, Catheter Tip
- Device Class
- Class II
- Regulation Number
- 870.2870
- Review Panel
- CV
- Submission Type