FDA 510(k)

OptoWire Deux

K-Nummer: K152991 · 2016-02-11

AntragstellerOpsens

Entscheidungsdatum2016-02-11

ProduktcodeDQX

BeratungsausschussCV

EntscheidungSubstantially Equivalent

Produktübersicht

OptoWire Deux is the device name listed in this FDA 510(k) record. The listed applicant is Opsens. It received FDA 510(k) clearance on 2016-02-11 under 510(k) number K152991. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the OptoWire Deux?

OptoWire Deux is a medical device that received FDA 510(k) clearance on 2016-02-11. The listed applicant is Opsens. The 510(k) number is K152991.

When did OptoWire Deux receive FDA 510(k) clearance?

OptoWire Deux received FDA 510(k) clearance on 2016-02-11, under 510(k) number K152991.

Who is the listed applicant for OptoWire Deux?

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

What is the FDA product code for OptoWire Deux?

The FDA product code for OptoWire Deux is DQX.

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Verwandte Geräte (Code: DQX)

K253146Hyperdrive 35 GuidewireRapid-Medical , Ltd.K261281CROSSLEAD Standard 035 and CROSSLEAD Stiff 035Filmecc Co., Ltd.K253667Accoat Guide WireSp Medical A/S K261640Merit 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.

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