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FDA 510(k)

QUICKWIRE - HYDROPHILIC COATED GUIDEWIRE

K-Number: K904582 · 1991-02-25

ApplicantMeadox Surgimed, Inc.
Decision Date1991-02-25
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

QUICKWIRE - HYDROPHILIC COATED GUIDEWIRE is the device name listed in this FDA 510(k) record. The listed applicant is Meadox Surgimed, Inc.. It received FDA 510(k) clearance on 1991-02-25 under 510(k) number K904582. 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 QUICKWIRE - HYDROPHILIC COATED GUIDEWIRE?

QUICKWIRE - HYDROPHILIC COATED GUIDEWIRE is a medical device that received FDA 510(k) clearance on 1991-02-25. The listed applicant is Meadox Surgimed, Inc.. The 510(k) number is K904582.

When did QUICKWIRE - HYDROPHILIC COATED GUIDEWIRE receive FDA 510(k) clearance?

QUICKWIRE - HYDROPHILIC COATED GUIDEWIRE received FDA 510(k) clearance on 1991-02-25, under 510(k) number K904582.

Who is the listed applicant for QUICKWIRE - HYDROPHILIC COATED GUIDEWIRE?

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

What is the FDA product code for QUICKWIRE - HYDROPHILIC COATED GUIDEWIRE?

The FDA product code for QUICKWIRE - HYDROPHILIC COATED GUIDEWIRE is DQX.

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Other records listing Meadox Surgimed, 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.

K944143MS CLASSIQUE BALLOON CATHETERK945061NOPROFILE OLBERT CATHETER SYSTEMK942382MS AMPLATZ EXTRA STIFF GUIDE WIREK930201ACECUT SUTOMATIC BIOPSY SYSTEMK911635MEADOX(R) SURGIMED(R) BIOPSY GUN IIK905181NO PROFILE OLBERT CATHETER SYSTEM FOR UROLOGY

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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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