510(k) K922541

USCI SUPER 9 PTCA GUIDING CATHETER by C.R. Bard, Inc. — Product Code DQI

K922541 is an FDA 510(k) premarket notification submitted by C.R. Bard, Inc. for the device "USCI SUPER 9 PTCA GUIDING CATHETER". The FDA issued a decision of Substantially Equivalent on December 8, 1992. The device falls under product code DQI (Withdrawal/Infusion Pump), a Class II device regulated under 21 CFR 870.1800. C.R. Bard, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 8, 1992
Date Received
May 29, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Withdrawal/Infusion Pump
Device Class
Class II
Regulation Number
870.1800
Review Panel
HO
Submission Type