510(k) K902256

IRRIGATION CATHETER 4, 6 AND 10 FRENCH by Applied Vascular Devices, Inc. — Product Code DQY

K902256 is an FDA 510(k) premarket notification submitted by Applied Vascular Devices, Inc. for the device "IRRIGATION CATHETER 4, 6 AND 10 FRENCH". The FDA issued a decision of Substantially Equivalent on February 15, 1991. The device falls under product code DQY (Catheter, Percutaneous), a Class II device regulated under 21 CFR 870.1250. Applied Vascular Devices, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 15, 1991
Date Received
May 21, 1990
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