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FDA 510(k)

M-PATH NITINOL GUIDEWIRE

K-Number: K946356 · 1995-03-31

ApplicantMicrovena Corp.
Decision Date1995-03-31
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

M-PATH NITINOL GUIDEWIRE is the device name listed in this FDA 510(k) record. The listed applicant is Microvena Corp.. It received FDA 510(k) clearance on 1995-03-31 under 510(k) number K946356. 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 M-PATH NITINOL GUIDEWIRE?

M-PATH NITINOL GUIDEWIRE is a medical device that received FDA 510(k) clearance on 1995-03-31. The listed applicant is Microvena Corp.. The 510(k) number is K946356.

When did M-PATH NITINOL GUIDEWIRE receive FDA 510(k) clearance?

M-PATH NITINOL GUIDEWIRE received FDA 510(k) clearance on 1995-03-31, under 510(k) number K946356.

Who is the listed applicant for M-PATH NITINOL GUIDEWIRE?

The FDA 510(k) record lists Microvena Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for M-PATH NITINOL GUIDEWIRE?

The FDA product code for M-PATH NITINOL GUIDEWIRE is DQX.

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Other records listing Microvena 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.

K991898ULTRA-SELECT GUIDEWIRE, HYTEK GUIDEWIREK991194MODIFICATION TO ULTRA-SELECT GUIDEWIREK982657AMPLATZ THROMBECTOMY DEVICE MODELS ATD 601, ATD 602, ATD 801, ATD 802, FOOT PEDAL ASSEMBLY MODEL AK 100K970668THE AMPLANTZ GOOSE NECK MICROSNAREK972511AMPLATZ GOOSE NECK SNARE KIT/ CATHETERK971984AMPLATZ THROMBECTOMY DEVICE(ATD 603,602,801,802)/FOOT PEDAL ASSEMBLY(AK 200)

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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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