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FDA 510(k)

NAVIGUIDE HYDROPHILIC GUIDE WIRE

K-Number: K943358 · 1995-06-02

ApplicantMeadox Medicals, Div. Boston Scientific Corp.
Decision Date1995-06-02
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

NAVIGUIDE HYDROPHILIC GUIDE WIRE is the device name listed in this FDA 510(k) record. The listed applicant is Meadox Medicals, Div. Boston Scientific Corp.. It received FDA 510(k) clearance on 1995-06-02 under 510(k) number K943358. 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 NAVIGUIDE HYDROPHILIC GUIDE WIRE?

NAVIGUIDE HYDROPHILIC GUIDE WIRE is a medical device that received FDA 510(k) clearance on 1995-06-02. The listed applicant is Meadox Medicals, Div. Boston Scientific Corp.. The 510(k) number is K943358.

When did NAVIGUIDE HYDROPHILIC GUIDE WIRE receive FDA 510(k) clearance?

NAVIGUIDE HYDROPHILIC GUIDE WIRE received FDA 510(k) clearance on 1995-06-02, under 510(k) number K943358.

Who is the listed applicant for NAVIGUIDE HYDROPHILIC GUIDE WIRE?

The FDA 510(k) record lists Meadox Medicals, Div. Boston Scientific Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NAVIGUIDE HYDROPHILIC GUIDE WIRE?

The FDA product code for NAVIGUIDE HYDROPHILIC GUIDE WIRE is DQX.

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Other records listing Meadox Medicals, Div. Boston Scientific Corp. 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.

K953647MS CLASSIQUE BALLOON CATHETER W/HYDROPASS COATINGK960766MEADOX MEDICALS, INC. EXPANDED PTFE VASCULAR GRAFTK962433MEADOX EXXCEL EPTFE VASCULAR GRAFTK961847HEMASHIELD VANTAGE (VASCULAR GRAFTK962342HEMASHIELD FINESSE ULTRA-THIN, KNITTED CARDIOVASCULAR PATCHK955460MEADOX MEDICALS, INC., EXPANDED & EXTERNALLY SUPPORTED EXPANDED PTFE VASCULAR GRAFT

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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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