510(k) K900483
K900483 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "VARIDYNE AT POSTOPERATIVE ORTHOPEDIC AUTOTRANSFU.". The FDA issued a decision of Substantially Equivalent on Aug 29, 1990. The device falls under product code CAC (Apparatus, Autotransfusion), a Class II device regulated under 21 CFR 868.5830. Baxter Healthcare Corp has 507 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 29, 1990
- Date Received
- Feb 1, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Apparatus, Autotransfusion
- Device Class
- Class II
- Regulation Number
- 868.5830
- Review Panel
- CV
- Submission Type
- 510(k)