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FDA 510(k)

ECHOMARK INTRAUTERINE GUIDING CATHETER

K-Number: K932436 · 1995-11-16

ApplicantEchocath, Inc.
Decision Date1995-11-16
Product CodeMOV
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

ECHOMARK INTRAUTERINE GUIDING CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Echocath, Inc.. It received FDA 510(k) clearance on 1995-11-16 under 510(k) number K932436. The device is classified under product code MOV. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ECHOMARK INTRAUTERINE GUIDING CATHETER?

ECHOMARK INTRAUTERINE GUIDING CATHETER is a medical device that received FDA 510(k) clearance on 1995-11-16. The listed applicant is Echocath, Inc.. The 510(k) number is K932436.

When did ECHOMARK INTRAUTERINE GUIDING CATHETER receive FDA 510(k) clearance?

ECHOMARK INTRAUTERINE GUIDING CATHETER received FDA 510(k) clearance on 1995-11-16, under 510(k) number K932436.

Who is the listed applicant for ECHOMARK INTRAUTERINE GUIDING CATHETER?

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 INTRAUTERINE GUIDING CATHETER?

The FDA product code for ECHOMARK INTRAUTERINE GUIDING CATHETER is MOV.

Related Clinical Trials

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.

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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 METERK933417ECHOMARK(R) ELECTROPHYSIOLOGY CATHETERK926351COLORMARK(TM) VISUALIZATION SYSTEMK922787ECHOMARK GUIDEWIRE WITH ULTRASONIC LOCALIZATION

Related Devices (Code: MOV)

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.

K180552Modified Novy Cornual Cannulation SetCook IncorporatedK931534OVAMED INTRAUTERINE ACCESS CATHETEROvamed Corp.K953314CONCEPTUS FALLOPIAN TUBE CATHETERIZATION SYSTEMConceptus, Inc.K931476NOVY CORNUAL CANNULATION SETCook Ob/Gyn

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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