510(k) K022167
K022167 is an FDA 510(k) premarket notification submitted by Pall Corp. for the device "PALL DONER PRE-EVACUATED POST-OPERATIVE AUTOLOGOUS BLOOD REINFUSION SYSTEM". The FDA issued a decision of Substantially Equivalent on March 7, 2003. The device falls under product code CAC (Apparatus, Autotransfusion), a Class II device regulated under 21 CFR 868.5830. Pall Corp. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 7, 2003
- Date Received
- July 3, 2002
- 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