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FDA 510(k)

ESSENCE GUIDEWIRE

K-Number: K955637 · 1996-03-11

ApplicantCordis Neurovascular, Inc.
Decision Date1996-03-11
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ESSENCE GUIDEWIRE 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 1996-03-11 under 510(k) number K955637. 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 ESSENCE GUIDEWIRE?

ESSENCE GUIDEWIRE is a medical device that received FDA 510(k) clearance on 1996-03-11. The listed applicant is Cordis Neurovascular, Inc.. The 510(k) number is K955637.

When did ESSENCE GUIDEWIRE receive FDA 510(k) clearance?

ESSENCE GUIDEWIRE received FDA 510(k) clearance on 1996-03-11, under 510(k) number K955637.

Who is the listed applicant for ESSENCE GUIDEWIRE?

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 ESSENCE GUIDEWIRE?

The FDA product code for ESSENCE GUIDEWIRE is DQX.

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Other records listing Cordis Neurovascular, Inc. as applicant

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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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