510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K792223Substantially Equivalent

Pacesetter Model 350

Cynergy, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K792223 is the FDA 510(k) clearance record for PACESETTER MODEL 350, a class II device, cleared for Cynergy on under FDA product code DTE (Pulse-Generator, Pacemaker, External). FDA records list 5 510(k) clearances for Cynergy, from to . As of , FDA records show no recalls naming K792223.

Clearance record

Decision date
Received
(25 days to decision)
Product code
DTE Pulse-Generator, Pacemaker, External
Regulation
21 CFR 870.3600
Device class
Class II
Review panel
Cardiovascular
Applicant
Cynergy 803 N. Front St. Suite 3, Mchenry IL
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