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FDA 510(k)

THE NINER NITINOL GUIDEWIRE

K-Number: K952860 · 1995-12-13

ApplicantMicrovena Corp.
Decision Date1995-12-13
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

THE NINER 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 1995-12-13 under 510(k) number K952860. 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 THE NINER NITINOL GUIDEWIRE?

THE NINER NITINOL GUIDEWIRE is a medical device that received FDA 510(k) clearance on 1995-12-13. The listed applicant is Microvena Corp.. The 510(k) number is K952860.

When did THE NINER NITINOL GUIDEWIRE receive FDA 510(k) clearance?

THE NINER NITINOL GUIDEWIRE received FDA 510(k) clearance on 1995-12-13, under 510(k) number K952860.

Who is the listed applicant for THE NINER 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 THE NINER NITINOL GUIDEWIRE?

The FDA product code for THE NINER 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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