510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K853138Substantially Equivalent

Millar Mikro-Tip Doppler Catheter

Millar LLC., Houston TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K853138 is the FDA 510(k) clearance record for MILLAR MIKRO-TIP DOPPLER CATHETER, a class II device, cleared for Millar Instruments, Inc. on under FDA product code JOP (Transducer, Ultrasonic). FDA records list 19 510(k) clearances for Millar LLC., from to . As of , FDA records show no recalls naming K853138.

Clearance record

Decision date
Received
(95 days to decision)
Product code
JOP Transducer, Ultrasonic
Regulation
21 CFR 870.2880
Device class
Class II
Review panel
Cardiovascular
Applicant
Millar Instruments, Inc. P.O. Box 18227, Houston TX
Third party review
No

Clearances, product code JOP

Trailing 12 months

FDA records hold no clearances under product code JOP in the trailing twelve months.

FDA records show no clearances under product code JOP in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JOP, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260