510(k) K823553

CORCATH H & B VASCULAR ACCESS CATHETER by Cormed, Inc., Sub. C.R.Bard, Inc. — Product Code LJS

K823553 is an FDA 510(k) premarket notification submitted by Cormed, Inc., Sub. C.R.Bard, Inc. for the device "CORCATH H & B VASCULAR ACCESS CATHETER". The FDA issued a decision of Substantially Equivalent on January 5, 1983. The device falls under product code LJS (Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days), a Class II device regulated under 21 CFR 880.5970. Cormed, Inc., Sub. C.R.Bard, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 5, 1983
Date Received
December 1, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Device Class
Class II
Regulation Number
880.5970
Review Panel
HO
Submission Type