510(k) K910204
K910204 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "SWAN-GANZ(R) HI-SHORE(R) THERMO CATH W/AMC(TM)". The FDA issued a decision of Substantially Equivalent on Apr 24, 1991. 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
- Apr 24, 1991
- Date Received
- Jan 16, 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)