510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K924661Substantially Equivalent

Swan-Ganz Intellicath Cco Thermodilution Catheter

Baxter Healthcare Corporation, Santa Ana CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K924661 is the FDA 510(k) clearance record for SWAN-GANZ INTELLICATH CCO THERMODILUTION CATHETER, a class II device, cleared for Baxter Healthcare Corp on under FDA product code KRA (Catheter, Continuous Flush). FDA records list 570 510(k) clearances for Baxter Healthcare Corp, from to . As of , FDA records show 3 recalls naming K924661.

Clearance record

Decision date
Received
(205 days to decision)
Product code
KRA Catheter, Continuous Flush
Regulation
21 CFR 870.1210
Device class
Class II
Review panel
Cardiovascular
Applicant
Baxter Healthcare Corp P O Box 11150, Santa Ana CA
510(k) summary
Statement
Third party review
No

Clearances, product code KRA

Trailing 12 months
5 clearances under product code KRA in the twelve months to October 2026, September 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code KRA, 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 20262
October 20260