510(k) K840958

DESERET LONG TERM INDWELLING CATHETER by Parke-Davis Co. — Product Code LJS

K840958 is an FDA 510(k) premarket notification submitted by Parke-Davis Co. for the device "DESERET LONG TERM INDWELLING CATHETER". The FDA issued a decision of Substantially Equivalent on April 17, 1984. 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. Parke-Davis Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 17, 1984
Date Received
March 6, 1984
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