510(k) K914984

E-Z-FLOW ANGIOGRAPHY CATHETERS, MODIFICATION by E-Z-Em, Inc. — Product Code DQY

K914984 is an FDA 510(k) premarket notification submitted by E-Z-Em, Inc. for the device "E-Z-FLOW ANGIOGRAPHY CATHETERS, MODIFICATION". The FDA issued a decision of Substantially Equivalent on May 20, 1992. The device falls under product code DQY (Catheter, Percutaneous), a Class II device regulated under 21 CFR 870.1250. E-Z-Em, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 20, 1992
Date Received
October 23, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Percutaneous
Device Class
Class II
Regulation Number
870.1250
Review Panel
CV
Submission Type