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FDA 510(k)

BRIDGEPOINT MEDICAL ENTERA PERCUTANEOUS CORONARY AND PERIPHERAL GUIDEWIRE, MODEL M-3001

K-Number: K081187 · 2008-10-08

ApplicantBridgepoint Medical
Decision Date2008-10-08
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BRIDGEPOINT MEDICAL ENTERA PERCUTANEOUS CORONARY AND PERIPHERAL GUIDEWIRE, MODEL M-3001 is the device name listed in this FDA 510(k) record. The listed applicant is Bridgepoint Medical. It received FDA 510(k) clearance on 2008-10-08 under 510(k) number K081187. 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 BRIDGEPOINT MEDICAL ENTERA PERCUTANEOUS CORONARY AND PERIPHERAL GUIDEWIRE, MODEL M-3001?

BRIDGEPOINT MEDICAL ENTERA PERCUTANEOUS CORONARY AND PERIPHERAL GUIDEWIRE, MODEL M-3001 is a medical device that received FDA 510(k) clearance on 2008-10-08. The listed applicant is Bridgepoint Medical. The 510(k) number is K081187.

When did BRIDGEPOINT MEDICAL ENTERA PERCUTANEOUS CORONARY AND PERIPHERAL GUIDEWIRE, MODEL M-3001 receive FDA 510(k) clearance?

BRIDGEPOINT MEDICAL ENTERA PERCUTANEOUS CORONARY AND PERIPHERAL GUIDEWIRE, MODEL M-3001 received FDA 510(k) clearance on 2008-10-08, under 510(k) number K081187.

Who is the listed applicant for BRIDGEPOINT MEDICAL ENTERA PERCUTANEOUS CORONARY AND PERIPHERAL GUIDEWIRE, MODEL M-3001?

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

What is the FDA product code for BRIDGEPOINT MEDICAL ENTERA PERCUTANEOUS CORONARY AND PERIPHERAL GUIDEWIRE, MODEL M-3001?

The FDA product code for BRIDGEPOINT MEDICAL ENTERA PERCUTANEOUS CORONARY AND PERIPHERAL GUIDEWIRE, MODEL M-3001 is DQX.

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Other records listing Bridgepoint Medical 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.

K122795STINGRAY GUIDEWIRESK121745MANTARAY GUIDEWIRESK120533BIGBOSS CATHETERS MANTATAY CATHETER MANTARAY GUIDEWIRESK120881MANTARAY GUIDEWIRESK120129MANTARAY CATHETERK113589BIGBOSS CATHETER

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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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