ECHOMARK GUIDEWIRE WITH ULTRASONIC LOCALIZATION— 510(k) K922787

Name: FDA 510(k) clearance K922787
Creator: U.S. Food and Drug Administration
Published: 1993-01-06

Substantially Equivalent

Echocath, Inc.

FDA 510(k) clearance K922787 for ECHOMARK GUIDEWIRE WITH ULTRASONIC LOCALIZATION, Substantially Equivalent on 1993-01-06. Applicant: Echocath, Inc.. Device class: 2.

Clearance details

Applicant: Echocath, Inc.
Product code: Code DQX
Device class: Class 2
Regulation: 21 CFR 870.1330
Advisory panel: Cardiovascular
Date received: 1992-06-09
Decision date: 1993-01-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Princeton, NJ, US

Download summary PDF View on FDA.gov ↗

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K254137 — InQwire Amplatz Guide Wire2026-05-22
K260544 — FMD Peripheral Guide Wire F-14 Flex 6 +4 more2026-03-20

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K010482 — ECHOFLOW PORTABLE DOPPLER BLOOD FLOW MEASUREMENT SYSTEM; MODEL PEF-12001-03-20
K990642 — ECHOFLOW DOPPLER BLOOD VELOCITY METER1999-09-16
K932436 — ECHOMARK INTRAUTERINE GUIDING CATHETER1995-11-16
K933417 — ECHOMARK(R) ELECTROPHYSIOLOGY CATHETER1995-05-04
K926351 — COLORMARK(TM) VISUALIZATION SYSTEM1993-09-16

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.