510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K910429Substantially Equivalent

Swan-Ganz Flow Directed Pressure Td Catheter

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

K910429 is the FDA 510(k) clearance record for SWAN-GANZ FLOW DIRECTED PRESSURE TD CATHETER, a class II device, cleared for Baxter Healthcare Corp on under FDA product code DXO (Transducer, Pressure, Catheter Tip). FDA records list 570 510(k) clearances for Baxter Healthcare Corp, from to . As of , FDA records show no recalls naming K910429.

Clearance record

Decision date
Received
(160 days to decision)
Product code
DXO Transducer, Pressure, Catheter Tip
Regulation
21 CFR 870.2870
Device class
Class II
Review panel
Cardiovascular
Applicant
Baxter Healthcare Corp P O Box 11150, Santa Ana CA
Third party review
No

Clearances, product code DXO

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