510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K913042Substantially Equivalent

Modifications to Series of Cardiac Catheters

Sentron, Inc., Federal Way WA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K913042 is the FDA 510(k) clearance record for MODIFICATIONS TO SERIES OF CARDIAC CATHETERS, a class II device, cleared for Sentron, Inc. on under FDA product code DXO (Transducer, Pressure, Catheter Tip). FDA records list one 510(k) clearance for Sentron, Inc. As of , FDA records show no recalls naming K913042.

Clearance record

Decision date
Received
(484 days to decision)
Product code
DXO Transducer, Pressure, Catheter Tip
Regulation
21 CFR 870.2870
Device class
Class II
Review panel
Cardiovascular
Applicant
Sentron, Inc. 34008 9th Ave. S., Federal Way WA
510(k) summary
Statement
Third party review
No

Clearances, product code DXO

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