510(k) K092644
K092644 is an FDA 510(k) premarket notification submitted by Terumo Cardiovascular Systems Corp. for the device "TERUMO PRESSURE ISOLATOR". The FDA issued a decision of Substantially Equivalent on December 10, 2009. The device falls under product code DRS (Transducer, Blood-Pressure, Extravascular), a Class II device regulated under 21 CFR 870.2850. Terumo Cardiovascular Systems Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 10, 2009
- Date Received
- August 27, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Transducer, Blood-Pressure, Extravascular
- Device Class
- Class II
- Regulation Number
- 870.2850
- Review Panel
- CV
- Submission Type