510(k) K915726
K915726 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "PULMONARY ARTERY FLOW-DIRECTED THERMODILUTION CATH". The FDA issued a decision of Substantially Equivalent on Sep 21, 1992. The device falls under product code DQO (Catheter, Intravascular, Diagnostic), a Class II device regulated under 21 CFR 870.1200. Baxter Healthcare Corp has 507 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 21, 1992
- Date Received
- Dec 20, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Catheter, Intravascular, Diagnostic
- Device Class
- Class II
- Regulation Number
- 870.1200
- Review Panel
- CV
- Submission Type
- 510(k)