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FDA 510(k)

MERIDIAN GUIDEWIRE

K-Number: K093681 · 2010-01-26

ApplicantEv3 Neurovascular
Decision Date2010-01-26
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MERIDIAN GUIDEWIRE is the device name listed in this FDA 510(k) record. The listed applicant is Ev3 Neurovascular. It received FDA 510(k) clearance on 2010-01-26 under 510(k) number K093681. 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 MERIDIAN GUIDEWIRE?

MERIDIAN GUIDEWIRE is a medical device that received FDA 510(k) clearance on 2010-01-26. The listed applicant is Ev3 Neurovascular. The 510(k) number is K093681.

When did MERIDIAN GUIDEWIRE receive FDA 510(k) clearance?

MERIDIAN GUIDEWIRE received FDA 510(k) clearance on 2010-01-26, under 510(k) number K093681.

Who is the listed applicant for MERIDIAN GUIDEWIRE?

The FDA 510(k) record lists Ev3 Neurovascular as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MERIDIAN GUIDEWIRE?

The FDA product code for MERIDIAN GUIDEWIRE is DQX.

Related Clinical Trials

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.

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Other records listing Ev3 Neurovascular 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.

K091458HYPERGLIDE OCCLUSION BALLOON SYSTEM, HYPERFORM OCCLUSION BALLOON SYSTEM, MODEL 104-4112, 104-4113, 104-4127,104-4132,104K092495HYPERGLIDE OCCLUSION BALLOON SYSTEM, MODEL 104-4310, 104-4315

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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