510(k) K893578
K893578 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "PHARMASEAL MEDI-VAC STERILE POST-OP AUTOTRANS. SYS". The FDA issued a decision of Substantially Equivalent on Aug 1, 1989. 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 1, 1989
- Date Received
- May 9, 1989
- 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)