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FDA 510(k)

ULTRA-SELECT PTCA GUIDEWIRE

K-Number: K910280 · 1991-04-19

ApplicantMicrovena Corp.
Decision Date1991-04-19
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ULTRA-SELECT PTCA 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 1991-04-19 under 510(k) number K910280. 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 ULTRA-SELECT PTCA GUIDEWIRE?

ULTRA-SELECT PTCA GUIDEWIRE is a medical device that received FDA 510(k) clearance on 1991-04-19. The listed applicant is Microvena Corp.. The 510(k) number is K910280.

When did ULTRA-SELECT PTCA GUIDEWIRE receive FDA 510(k) clearance?

ULTRA-SELECT PTCA GUIDEWIRE received FDA 510(k) clearance on 1991-04-19, under 510(k) number K910280.

Who is the listed applicant for ULTRA-SELECT PTCA 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 ULTRA-SELECT PTCA GUIDEWIRE?

The FDA product code for ULTRA-SELECT PTCA 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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