510(k) K910429
K910429 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "SWAN-GANZ FLOW DIRECTED PRESSURE TD CATHETER". The FDA issued a decision of Substantially Equivalent on Jul 11, 1991. The device falls under product code DXO (Transducer, Pressure, Catheter Tip), a Class II device regulated under 21 CFR 870.2870. Baxter Healthcare Corp has 507 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 11, 1991
- Date Received
- Feb 1, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Transducer, Pressure, Catheter Tip
- Device Class
- Class II
- Regulation Number
- 870.2870
- Review Panel
- CV
- Submission Type
- 510(k)