GRADUATED GUIDE WIRE BOWL 8— 510(k) K834237

Name: FDA 510(k) clearance K834237
Creator: U.S. Food and Drug Administration
Published: 1984-02-04

Substantially Equivalent

Sterile Design, Inc.

FDA 510(k) clearance K834237 for GRADUATED GUIDE WIRE BOWL 8, Substantially Equivalent on 1984-02-04. Applicant: Sterile Design, Inc.. Device class: 2.

Clearance details

Applicant: Sterile Design, Inc.
Product code: Code DQX
Device class: Class 2
Regulation: 21 CFR 870.1330
Advisory panel: Cardiovascular
Date received: 1983-12-06
Decision date: 1984-02-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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More clearances from Sterile Design, Inc.

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K934688 — STERILE DESIGN1994-03-16
K841960 — CARDIO METRICS INVASIVE PRESSURE MONIT1985-11-08
K842356 — CUSTOM STERILE PROCEDURE KITS1985-03-21
K841959 — CARDIO METRIC CUSTOM PERFUSION TUBING1984-10-19
K841958 — CARDIO METRICS CARDIOTOMY RESERVOIR1984-10-15

Adverse events under product code DQX

product code DQX

Death: 298
Injury: 4,385
Malfunction: 7,203
Other: 5
Total: 11,891

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.