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FDA 510(k)

PERCU-PRO GUIDEWIRE

K-Number: K094062 · 2010-09-27

ApplicantCardiosolutions, Inc.
Decision Date2010-09-27
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PERCU-PRO GUIDEWIRE is the device name listed in this FDA 510(k) record. The listed applicant is Cardiosolutions, Inc.. It received FDA 510(k) clearance on 2010-09-27 under 510(k) number K094062. 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 PERCU-PRO GUIDEWIRE?

PERCU-PRO GUIDEWIRE is a medical device that received FDA 510(k) clearance on 2010-09-27. The listed applicant is Cardiosolutions, Inc.. The 510(k) number is K094062.

When did PERCU-PRO GUIDEWIRE receive FDA 510(k) clearance?

PERCU-PRO GUIDEWIRE received FDA 510(k) clearance on 2010-09-27, under 510(k) number K094062.

Who is the listed applicant for PERCU-PRO GUIDEWIRE?

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

What is the FDA product code for PERCU-PRO GUIDEWIRE?

The FDA product code for PERCU-PRO 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 Cardiosolutions, Inc. 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.

K131332CARDIOSOLUTIONS PERCU-PRO STEERABLE INTRODUCERK094048PERCUPRO MESSENGER BALLOON CATHETER

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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