510(k) K896466
K896466 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "SWAN-GANZ THERMODILUTION EJECTION FRACTION/VOLUME". The FDA issued a decision of Substantially Equivalent on Feb 8, 1990. The device falls under product code DYG (Catheter, Flow Directed), a Class II device regulated under 21 CFR 870.1240. Baxter Healthcare Corp has 507 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 8, 1990
- Date Received
- Nov 13, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Catheter, Flow Directed
- Device Class
- Class II
- Regulation Number
- 870.1240
- Review Panel
- CV
- Submission Type
- 510(k)