510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K181836Substantially Equivalent

4F Infiniti Angiographic Catheter, 4F & 5F Nylex Angiography Catheters, 4F & 5F Tempo Angiography Catheters

Cordis, A Cardinal Health Company, Milpitas CA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K181836 is the FDA 510(k) clearance record for 4F Infiniti Angiographic Catheter, 4F & 5F Nylex Angiography Catheters, 4F & 5F Tempo Angiography Catheters, a class II device, cleared for Cordis, A Cardinal Health Company on under FDA product code DQO (Catheter, Intravascular, Diagnostic). FDA records list one 510(k) clearance for Cordis, A Cardinal Health Company. As of , FDA records show no recalls naming K181836.

Clearance record

Decision date
Received
(29 days to decision)
Product code
DQO Catheter, Intravascular, Diagnostic
Regulation
21 CFR 870.1200
Device class
Class II
Review panel
Cardiovascular
Applicant
Cordis, A Cardinal Health Company 1820 Mccarthy Blvd., Milpitas CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DQO

Trailing 12 months
3 clearances under product code DQO in the twelve months to October 2026, March 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DQO, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20260
May 20261
June 20261
July 20260
August 20260
September 20260
October 20260