TEFLON COATED GUIDEWIRE— 510(k) K902153

Name: FDA 510(k) clearance K902153
Creator: U.S. Food and Drug Administration
Published: 1990-07-31

Substantially Equivalent

Guidewire Technologies, Inc.

FDA 510(k) clearance K902153 for TEFLON COATED GUIDEWIRE, Substantially Equivalent on 1990-07-31. Applicant: Guidewire Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Guidewire Technologies, Inc.
Product code: Code DQX
Device class: Class 2
Regulation: 21 CFR 870.1330
Advisory panel: Cardiovascular
Date received: 1990-05-16
Decision date: 1990-07-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salem, NH, US

Download summary PDF View on FDA.gov ↗

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More clearances from Guidewire Technologies, Inc.

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K902152 — MOVABLE CORE GUIDEWIRE1990-07-31
K890959 — GUIDEWIRE1989-09-12

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.