510(k) K860526
K860526 is an FDA 510(k) premarket notification submitted by Nova Medical Specialties for the device "NOVA BALLOON THERMODILUTION PRESSURE TRANS CATH". The FDA issued a decision of Substantially Equivalent on May 2, 1986. The device falls under product code DXO (Transducer, Pressure, Catheter Tip), a Class II device regulated under 21 CFR 870.2870. Nova Medical Specialties has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 2, 1986
- Date Received
- February 11, 1986
- 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