510(k) K841251

DESERET HEPARIN COATED FLOW CATH by Parke-Davis Co. — Product Code DYG

K841251 is an FDA 510(k) premarket notification submitted by Parke-Davis Co. for the device "DESERET HEPARIN COATED FLOW CATH". The FDA issued a decision of Substantially Equivalent on June 11, 1984. The device falls under product code DYG (Catheter, Flow Directed), a Class II device regulated under 21 CFR 870.1240. Parke-Davis Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 11, 1984
Date Received
March 26, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Flow Directed
Device Class
Class II
Regulation Number
870.1240
Review Panel
CV
Submission Type