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FDA 510(k)

ENVOY GUIDING CATHETER

K-Number: K940187 · 1994-03-30

ApplicantCordis Neurovascular, Inc.
Decision Date1994-03-30
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ENVOY GUIDING CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Cordis Neurovascular, Inc.. It received FDA 510(k) clearance on 1994-03-30 under 510(k) number K940187. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENVOY GUIDING CATHETER?

ENVOY GUIDING CATHETER is a medical device that received FDA 510(k) clearance on 1994-03-30. The listed applicant is Cordis Neurovascular, Inc.. The 510(k) number is K940187.

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

ENVOY GUIDING CATHETER received FDA 510(k) clearance on 1994-03-30, under 510(k) number K940187.

Who is the listed applicant for ENVOY GUIDING CATHETER?

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

What is the FDA product code for ENVOY GUIDING CATHETER?

The FDA product code for ENVOY GUIDING CATHETER is DQY.

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Other records listing Cordis Neurovascular, Inc. as applicant

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Related Devices (Code: DQY)

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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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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