CORATOMIC #VX5-105 & VX5-205 PULSE GEN.— 510(k) K822791

Substantially Equivalent

Coratomic, Inc.

FDA 510(k) clearance K822791 for CORATOMIC #VX5-105 & VX5-205 PULSE GEN., Substantially Equivalent on 1982-12-15. Applicant: Coratomic, Inc..

Clearance details

Applicant: Coratomic, Inc.
Product code: Code DXY
Advisory panel: Cardiovascular
Date received: 1982-09-15
Decision date: 1982-12-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

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Adverse events under product code DXY

product code DXY

Death: 240
Injury: 2,328
Malfunction: 2,096
Total: 4,664

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.