510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K894286Substantially Equivalent

Ppg Biomedical Flexible Micro Transducer Catheter

Ppg Industries, Inc., Pleasantville NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K894286 is the FDA 510(k) clearance record for PPG BIOMEDICAL FLEXIBLE MICRO TRANSDUCER CATHETER, a class II device, cleared for Ppg Industries, Inc. on under FDA product code DXO (Transducer, Pressure, Catheter Tip). FDA records list 20 510(k) clearances for Ppg Industries, Inc., from to . As of , FDA records show no recalls naming K894286.

Clearance record

Decision date
Received
(111 days to decision)
Product code
DXO Transducer, Pressure, Catheter Tip
Regulation
21 CFR 870.2870
Device class
Class II
Review panel
Cardiovascular
Applicant
Ppg Industries, Inc. One Campus Dr., Pleasantville NY
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