510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K190612Substantially Equivalent

EQUINOX Balloon Dilatation Catheter

Dornier Medtech America, Inc., Kennesaw GA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K190612 is the FDA 510(k) clearance record for EQUINOX Balloon Dilatation Catheter, a class II device, cleared for Dornier Medtech America, Inc. on under FDA product code EZN (Dilator, Catheter, Ureteral). FDA records list 46 510(k) clearances for Dornier Medtech America, Inc., from to . As of , FDA records show no recalls naming K190612.

Clearance record

Decision date
Received
(270 days to decision)
Product code
EZN Dilator, Catheter, Ureteral
Regulation
21 CFR 876.5470
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Dornier Medtech America, Inc. 1155 Roberts Blvd., Suite 100, Kennesaw GA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code EZN

Trailing 12 months

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

FDA records show no clearances under product code EZN in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code EZN, 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