510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K893094Substantially Equivalent

Hb 1000, Brugada Electrophysiology System

Heartware Intl. Corp., New York NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K893094 is the FDA 510(k) clearance record for HB 1000, BRUGADA ELECTROPHYSIOLOGY SYSTEM, a class II device, cleared for Heartware Intl. Corp. on under FDA product code JOQ (Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)). FDA records list 4 510(k) clearances for Heartware Intl. Corp., from to . As of , FDA records show no recalls naming K893094.

Clearance record

Decision date
Received
(157 days to decision)
Product code
JOQ Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)
Regulation
21 CFR 870.1750
Device class
Class II
Review panel
Cardiovascular
Applicant
Heartware Intl. Corp. 2901 Broadway, New York NY
Third party review
No

Clearances, product code JOQ

Trailing 12 months

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

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