SWITCHING UNIT ELECTRODE CATHETERS— 510(k) K823361

Name: FDA 510(k) clearance K823361
Creator: U.S. Food and Drug Administration
Published: 1983-01-14

Substantially Equivalent

Webster Laboratories, Inc.

FDA 510(k) clearance K823361 for SWITCHING UNIT ELECTRODE CATHETERS, Substantially Equivalent on 1983-01-14. Applicant: Webster Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Webster Laboratories, Inc.
Product code: Code DRF
Device class: Class 2
Regulation: 21 CFR 870.1220
Advisory panel: Cardiovascular
Date received: 1982-11-09
Decision date: 1983-01-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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More clearances from Webster Laboratories, Inc.

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K853383 — CARDIOVASCULAR, THERMODILUTION, FLOW, CORONARY SIN1985-12-03
K841802 — ELECTRODE CATHETER, ORTHOGONAL TYPE1984-10-18
K834602 — SWITCHING UNIT ELECTRODE CATHETER1984-05-09
K813271 — TEMPERATURE PROBES1981-12-29

Adverse events under product code DRF

product code DRF

Death: 127
Injury: 1,676
Malfunction: 2,003
Other: 1
Total: 3,807

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.