510(k) K942791

ARGYLE AQUA-SEAL CONTINUOUS AUTOTRANSFUSION CHEST DRAINAGE UNIT by Sherwood Medical Co. — Product Code CAC

K942791 is an FDA 510(k) premarket notification submitted by Sherwood Medical Co. for the device "ARGYLE AQUA-SEAL CONTINUOUS AUTOTRANSFUSION CHEST DRAINAGE UNIT". The FDA issued a decision of Substantially Equivalent on May 10, 1995. The device falls under product code CAC (Apparatus, Autotransfusion), a Class II device regulated under 21 CFR 868.5830. Sherwood Medical Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 10, 1995
Date Received
June 14, 1994
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