510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K092364Substantially Equivalent

Model 220 Patient Magnet

LivaNova USA, Inc., Houston TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K092364 is the FDA 510(k) clearance record for MODEL 220 PATIENT MAGNET, a class I device, cleared for Cyberonics, Inc. on under FDA product code DTG (Magnet, Test, Pacemaker). FDA records list 49 510(k) clearances for LivaNova USA, INC., from to . As of , FDA records show no recalls naming K092364.

Clearance record

Decision date
Received
(90 days to decision)
Product code
DTG Magnet, Test, Pacemaker
Regulation
21 CFR 870.3690
Device class
Class I
Review panel
Cardiovascular
Applicant
Cyberonics, Inc. 100 Cyberonics Blvd., Houston TX
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DTG

Trailing 12 months

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

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