510(k) K890492
K890492 is an FDA 510(k) premarket notification submitted by Endosonics Corp. for the device "PRECEPT-PT(TM) MICROSENSOR PRESSURE MONITOR CATH.". The FDA issued a decision of Substantially Equivalent on March 2, 1989. The device falls under product code DXO (Transducer, Pressure, Catheter Tip), a Class II device regulated under 21 CFR 870.2870. Endosonics Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 2, 1989
- Date Received
- January 31, 1989
- 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