PACESETTER MODEL 350— 510(k) K792223

Name: FDA 510(k) clearance K792223
Creator: U.S. Food and Drug Administration
Published: 1979-11-30

Substantially Equivalent

Cynergy

FDA 510(k) clearance K792223 for PACESETTER MODEL 350, Substantially Equivalent on 1979-11-30. Applicant: Cynergy. Device class: 2.

Clearance details

Applicant: Cynergy
Product code: Code DTE
Device class: Class 2
Regulation: 21 CFR 870.3600
Advisory panel: Cardiovascular
Date received: 1979-11-05
Decision date: 1979-11-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K201011 — Medtronic Model 5392 External Pulse Generator (EPG)2020-05-13
K190825 — Medtronic Model 5392 External Pulse Generator (EPG)2019-04-30
K182839 — Lifetech Cardio Model 8301 Temporary Pacemaker2019-02-28

More clearances from Cynergy

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K810566 — SIEMENS MODEL 146-146A EXTERNAL PULSE G1981-04-01
K801596 — CYNERGY MODEL 1841980-09-16
K792536 — CYNERGY MODEL 1821980-01-31
K781407 — ERM-1011978-09-27

Adverse events under product code DTE

product code DTE

Death: 18
Injury: 247
Malfunction: 4,603
Total: 4,868

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.