510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K922541Substantially Equivalent

Usci Super 9 Ptca Guiding Catheter

C.R. Bard Inc, Billerica MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K922541 is the FDA 510(k) clearance record for USCI SUPER 9 PTCA GUIDING CATHETER, a class II device, cleared for C.R. Bard, Inc. on under FDA product code DQI (Withdrawal/Infusion Pump). FDA records list 646 510(k) clearances for C.R. Bard, Inc., from to . As of , FDA records show no recalls naming K922541.

Clearance record

Decision date
Received
(193 days to decision)
Product code
DQI Withdrawal/Infusion Pump
Regulation
21 CFR 870.1800
Device class
Class II
Review panel
Cardiovascular
Applicant
C.R. Bard, Inc. 1200 Technology Park Dr., Billerica MA
510(k) summary
Summary
Third party review
No

Clearances, product code DQI

Trailing 12 months

FDA records hold no clearances under product code DQI in the trailing twelve months.

FDA records show no clearances under product code DQI in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DQI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260