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FDA 510(k)

FINDRWIRZ GUIDE WIRE SYSTEM

K-Number: K080364 · 2008-08-11

ApplicantSentreheart, Inc.
Decision Date2008-08-11
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FINDRWIRZ GUIDE WIRE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Sentreheart, Inc.. It received FDA 510(k) clearance on 2008-08-11 under 510(k) number K080364. 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 FINDRWIRZ GUIDE WIRE SYSTEM?

FINDRWIRZ GUIDE WIRE SYSTEM is a medical device that received FDA 510(k) clearance on 2008-08-11. The listed applicant is Sentreheart, Inc.. The 510(k) number is K080364.

When did FINDRWIRZ GUIDE WIRE SYSTEM receive FDA 510(k) clearance?

FINDRWIRZ GUIDE WIRE SYSTEM received FDA 510(k) clearance on 2008-08-11, under 510(k) number K080364.

Who is the listed applicant for FINDRWIRZ GUIDE WIRE SYSTEM?

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

What is the FDA product code for FINDRWIRZ GUIDE WIRE SYSTEM?

The FDA product code for FINDRWIRZ GUIDE WIRE SYSTEM 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 Sentreheart, 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.

K090385LARIAT II SUTURE DELIVERY DEVICEK070126OCCLUSION 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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