510(k) K893394

ORTHOPEDIC WOUND DRAINAGE SET WITH TROCAR by Haemonetics Corp. — Product Code CAC

K893394 is an FDA 510(k) premarket notification submitted by Haemonetics Corp. for the device "ORTHOPEDIC WOUND DRAINAGE SET WITH TROCAR". The FDA issued a decision of Substantially Equivalent on October 19, 1989. The device falls under product code CAC (Apparatus, Autotransfusion), a Class II device regulated under 21 CFR 868.5830. Haemonetics Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 19, 1989
Date Received
May 1, 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