ERA-20— 510(k) K853194

Name: FDA 510(k) clearance K853194
Creator: U.S. Food and Drug Administration
Published: 1987-03-11

Substantially Equivalent

Biotronik Sales, Inc.

FDA 510(k) clearance K853194 for ERA-20, Substantially Equivalent on 1987-03-11. Applicant: Biotronik Sales, Inc.. Device class: 2.

Clearance details

Applicant: Biotronik Sales, Inc.
Product code: Code DTE
Device class: Class 2
Regulation: 21 CFR 870.3600
Advisory panel: Cardiovascular
Date received: 1985-07-30
Decision date: 1987-03-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lake Oswego, OR, US

Download summary PDF View on FDA.gov ↗

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More clearances from Biotronik Sales, Inc.

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K875199 — NP BIPOLAR ENDOCARDIAL LEAD W/VS-1 CONNECTOR1988-02-18
K860036 — EDP-20 PACEMAKER1987-01-12
K863878 — TRIOS-M VS-1 PULSE GENERATOR1986-12-10
K863879 — NEOS-M VS-1 PULSE GENERATOR1986-12-10
K863480 — BIOTRONIK PERMANENT PACEMAKER ELECTRODE1986-09-23

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.