510(k) K093111
K093111 is an FDA 510(k) premarket notification submitted by Millar Instruments, Inc. for the device "MIKRO-CATH, MODEL 825-0101". The FDA issued a decision of Substantially Equivalent on January 5, 2010. 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
- January 5, 2010
- Date Received
- October 1, 2009
- Clearance Type
- Abbreviated
- 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