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
K023080Substantially Equivalent

Galix Pacestar

Galix Biomedical Instrumentation, Inc., Miami Beach FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K023080 is the FDA 510(k) clearance record for GALIX PACESTAR, a class II device, cleared for Galix Biomedical Instrumentation, Inc. on under FDA product code DTE (Pulse-Generator, Pacemaker, External). FDA records list 6 510(k) clearances for Galix Biomedical Instrumentation, Inc., from to . As of , FDA records show no recalls naming K023080.

Clearance record

Decision date
Received
(267 days to decision)
Product code
DTE Pulse-Generator, Pacemaker, External
Regulation
21 CFR 870.3600
Device class
Class II
Review panel
Cardiovascular
Applicant
Galix Biomedical Instrumentation, Inc. 2555 Collins Ave., C-5, Miami Beach FL
510(k) summary
Statement
Third party review
No

Clearances, product code DTE

Trailing 12 months

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

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