510(k) K770535

C-DAK 3500 by Cordis Corp. — Product Code FIG

K770535 is an FDA 510(k) premarket notification submitted by Cordis Corp. for the device "C-DAK 3500". The FDA issued a decision of Substantially Equivalent on April 15, 1977. The device falls under product code FIG (Clamp, Tubing, Blood, Automatic), a Class II device regulated under 21 CFR 876.5820. Cordis Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 15, 1977
Date Received
March 21, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Clamp, Tubing, Blood, Automatic
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type