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FDA 510(k)

ECHOMARK GUIDEWIRE WITH ULTRASONIC LOCALIZATION

K-Number: K922787 · 1993-01-06

ApplicantEchocath, Inc.
Decision Date1993-01-06
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ECHOMARK GUIDEWIRE WITH ULTRASONIC LOCALIZATION is the device name listed in this FDA 510(k) record. The listed applicant is Echocath, Inc.. It received FDA 510(k) clearance on 1993-01-06 under 510(k) number K922787. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ECHOMARK GUIDEWIRE WITH ULTRASONIC LOCALIZATION?

ECHOMARK GUIDEWIRE WITH ULTRASONIC LOCALIZATION is a medical device that received FDA 510(k) clearance on 1993-01-06. The listed applicant is Echocath, Inc.. The 510(k) number is K922787.

When did ECHOMARK GUIDEWIRE WITH ULTRASONIC LOCALIZATION receive FDA 510(k) clearance?

ECHOMARK GUIDEWIRE WITH ULTRASONIC LOCALIZATION received FDA 510(k) clearance on 1993-01-06, under 510(k) number K922787.

Who is the listed applicant for ECHOMARK GUIDEWIRE WITH ULTRASONIC LOCALIZATION?

The FDA 510(k) record lists Echocath, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ECHOMARK GUIDEWIRE WITH ULTRASONIC LOCALIZATION?

The FDA product code for ECHOMARK GUIDEWIRE WITH ULTRASONIC LOCALIZATION is DQX.

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Other records listing Echocath, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K010482ECHOFLOW PORTABLE DOPPLER BLOOD FLOW MEASUREMENT SYSTEM; MODEL PEF-1K990642ECHOFLOW DOPPLER BLOOD VELOCITY METERK932436ECHOMARK INTRAUTERINE GUIDING CATHETERK933417ECHOMARK(R) ELECTROPHYSIOLOGY CATHETERK926351COLORMARK(TM) VISUALIZATION SYSTEM

Related Devices (Code: DQX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253146Hyperdrive 35 GuidewireRapid-Medical , Ltd.K261281CROSSLEAD Standard 035 and CROSSLEAD Stiff 035Filmecc Co., Ltd.K253667Accoat Guide WireSp Medical A/SK261640Merit MAK Nitinol/Gold-Tungsten Guide WireMerit Medical Ireland , Ltd.K254137InQwire Amplatz Guide WireMerit Medical Ireland, Ltd.K260544FMD Peripheral Guide Wire F-14 Flex 6; FMD Peripheral Guide Wire F-14 Tapered 40; FMD Peripheral Guide Wire F-18 Flex SP; FMD Peripheral Guide Wire F-18 DP 25; FMD Peripheral Guide Wire F-18 Tapered 40FMD Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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