VXTRA BACK PACK EKG ELECTRODE CAT. NO.— 510(k) K792436

Name: FDA 510(k) clearance K792436
Creator: U.S. Food and Drug Administration
Published: 1980-02-22

Substantially Equivalent

Vxtra Corp.

FDA 510(k) clearance K792436 for VXTRA BACK PACK EKG ELECTRODE CAT. NO., Substantially Equivalent on 1980-02-22. Applicant: Vxtra Corp.. Device class: 2.

Clearance details

Applicant: Vxtra Corp.
Product code: Code DRX
Device class: Class 2
Regulation: 21 CFR 870.2360
Advisory panel: Cardiovascular
Date received: 1979-11-28
Decision date: 1980-02-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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More clearances from Vxtra Corp.

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K832938 — OCUTOME PARATUBING SET1983-10-19
K832980 — VXTRA OCUTOME KIT1983-10-19
K831266 — MICROSURGICAL KNIFE1983-06-10
K830379 — PHAKO KIT1983-04-05
K830385 — IRRIGATION/ASPIRATION KIT1983-04-05

Adverse events under product code DRX

product code DRX

Death: 6
Injury: 476
Other: 2
Total: 484

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.