510(k) K792177
K792177 is an FDA 510(k) premarket notification submitted by Millar Instruments, Inc. for the device "MILLAR MIKRO-TIP CATHETER TRANSDUCER". The FDA issued a decision of Substantially Equivalent on November 15, 1979. 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
- November 15, 1979
- Date Received
- October 30, 1979
- Clearance Type
- Traditional
- 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