510(k) K894168
K894168 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "SWAN-GANZ THERM CATH SM HEART AMC THROM 93A102H5F". The FDA issued a decision of Substantially Equivalent on Nov 27, 1989. 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
- Nov 27, 1989
- Date Received
- Jun 15, 1989
- 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)