510(k) K953300

V-CATH DUAL LUMEN E.S.P. PERIPHERAL INSERTED CENTRAL CATHETER by Hdc Corp. — Product Code LJS

K953300 is an FDA 510(k) premarket notification submitted by Hdc Corp. for the device "V-CATH DUAL LUMEN E.S.P. PERIPHERAL INSERTED CENTRAL CATHETER". The FDA issued a decision of Substantially Equivalent on April 30, 1996. 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. Hdc Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 30, 1996
Date Received
July 14, 1995
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