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FDA 510(k)

SCHNEIDER MONORAIL-GEX(TM) GUIDEWIRE EXCHANGE CATH

K-Number: K902587 · 1990-12-03

ApplicantSchneider Intl., Ltd.
Decision Date1990-12-03
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SCHNEIDER MONORAIL-GEX(TM) GUIDEWIRE EXCHANGE CATH is the device name listed in this FDA 510(k) record. The listed applicant is Schneider Intl., Ltd.. It received FDA 510(k) clearance on 1990-12-03 under 510(k) number K902587. 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 SCHNEIDER MONORAIL-GEX(TM) GUIDEWIRE EXCHANGE CATH?

SCHNEIDER MONORAIL-GEX(TM) GUIDEWIRE EXCHANGE CATH is a medical device that received FDA 510(k) clearance on 1990-12-03. The listed applicant is Schneider Intl., Ltd.. The 510(k) number is K902587.

When did SCHNEIDER MONORAIL-GEX(TM) GUIDEWIRE EXCHANGE CATH receive FDA 510(k) clearance?

SCHNEIDER MONORAIL-GEX(TM) GUIDEWIRE EXCHANGE CATH received FDA 510(k) clearance on 1990-12-03, under 510(k) number K902587.

Who is the listed applicant for SCHNEIDER MONORAIL-GEX(TM) GUIDEWIRE EXCHANGE CATH?

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

What is the FDA product code for SCHNEIDER MONORAIL-GEX(TM) GUIDEWIRE EXCHANGE CATH?

The FDA product code for SCHNEIDER MONORAIL-GEX(TM) GUIDEWIRE EXCHANGE CATH is DQY.

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Other records listing Schneider Intl., Ltd. 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.

K925406BILIARY ENDOPROSTHESES W/UNISTEP DELIVERY SYSTEMK931577SCHNEIDER MAGNUM PERIPHERAL RECANALIZATION GUIDEWIK926271SCHNEIDER MATCH-35 PERCUTANEOUS TRANSLUMINAL ANGIOK926003SCHNEIDER SOFTIP SST ANGIOGRAPHIC (DIAG) CATHETERK925804SCHNEIDER HYDRO-SIL GUIDEWIREK924591SCHNEIDER SOLID-7 SOPTIP GUIDING CATHETER

View all 22 devices →

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.

K262817CrossFAST Integrated Microcatheter Advanced Delivery SystemVantis Vascular, Inc.K260559NHanceITIMDS Operation B.V.K262392APRO 35 Swift CatheterAlembic, LLCK262240SSPC NXT Delivery CatheterCenterPoint Systems, LLCK261766CPS Locator 3D Plus Delivery CatheterCenterPoint Systems, LLCK261825Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP CatheterAbbott

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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