510(k) K833573

CENTRAL VEIN CATH. TRAY CC-20-1420 by Intermed, Inc. — Product Code DQY

K833573 is an FDA 510(k) premarket notification submitted by Intermed, Inc. for the device "CENTRAL VEIN CATH. TRAY CC-20-1420". The FDA issued a decision of Substantially Equivalent on January 11, 1984. The device falls under product code DQY (Catheter, Percutaneous), a Class II device regulated under 21 CFR 870.1250. Intermed, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 11, 1984
Date Received
October 12, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Percutaneous
Device Class
Class II
Regulation Number
870.1250
Review Panel
CV
Submission Type