510(k) K961527

MX703 AND MX730 CONTINUOUS FLUSH DEVICES by Medex, Inc. — Product Code KRA

K961527 is an FDA 510(k) premarket notification submitted by Medex, Inc. for the device "MX703 AND MX730 CONTINUOUS FLUSH DEVICES". The FDA issued a decision of Substantially Equivalent on June 6, 1996. The device falls under product code KRA (Catheter, Continuous Flush), a Class II device regulated under 21 CFR 870.1210. Medex, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 6, 1996
Date Received
April 22, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Continuous Flush
Device Class
Class II
Regulation Number
870.1210
Review Panel
CV
Submission Type