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FDA 510(k)

GUIDEWIRE, PURSUER SERIES

K-Number: K130104 · 2013-06-13

ApplicantOscor, Inc.
Decision Date2013-06-13
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

GUIDEWIRE, PURSUER SERIES is the device name listed in this FDA 510(k) record. The listed applicant is Oscor, Inc.. It received FDA 510(k) clearance on 2013-06-13 under 510(k) number K130104. 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 GUIDEWIRE, PURSUER SERIES?

GUIDEWIRE, PURSUER SERIES is a medical device that received FDA 510(k) clearance on 2013-06-13. The listed applicant is Oscor, Inc.. The 510(k) number is K130104.

When did GUIDEWIRE, PURSUER SERIES receive FDA 510(k) clearance?

GUIDEWIRE, PURSUER SERIES received FDA 510(k) clearance on 2013-06-13, under 510(k) number K130104.

Who is the listed applicant for GUIDEWIRE, PURSUER SERIES?

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

What is the FDA product code for GUIDEWIRE, PURSUER SERIES?

The FDA product code for GUIDEWIRE, PURSUER SERIES is DQX.

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Other records listing Oscor, Inc. as applicant

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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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