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FDA 510(k)

BRIDGEPOINT MEDICAL CROSSBOSS PERCUTANEOUS CORONARY CATHETER

K-Number: K081130 · 2009-05-14

ApplicantBridgepoint Medical
Decision Date2009-05-14
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BRIDGEPOINT MEDICAL CROSSBOSS PERCUTANEOUS CORONARY CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Bridgepoint Medical. It received FDA 510(k) clearance on 2009-05-14 under 510(k) number K081130. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BRIDGEPOINT MEDICAL CROSSBOSS PERCUTANEOUS CORONARY CATHETER?

BRIDGEPOINT MEDICAL CROSSBOSS PERCUTANEOUS CORONARY CATHETER is a medical device that received FDA 510(k) clearance on 2009-05-14. The listed applicant is Bridgepoint Medical. The 510(k) number is K081130.

When did BRIDGEPOINT MEDICAL CROSSBOSS PERCUTANEOUS CORONARY CATHETER receive FDA 510(k) clearance?

BRIDGEPOINT MEDICAL CROSSBOSS PERCUTANEOUS CORONARY CATHETER received FDA 510(k) clearance on 2009-05-14, under 510(k) number K081130.

Who is the listed applicant for BRIDGEPOINT MEDICAL CROSSBOSS PERCUTANEOUS CORONARY CATHETER?

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 CROSSBOSS PERCUTANEOUS CORONARY CATHETER?

The FDA product code for BRIDGEPOINT MEDICAL CROSSBOSS PERCUTANEOUS CORONARY CATHETER is DQY.

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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: DQY)

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.

K262817CrossFAST Integrated Microcatheter Advanced Delivery SystemVantis Vascular, Inc.K260559NHanceITIMDS Operation B.V.K262392APRO 35 Swift CatheterAlembic, LLCK262240SSPC NXT Delivery CatheterCenterPoint Systems, LLCK261766CPS Locator 3D Plus Delivery CatheterCenterPoint Systems, LLCK261825Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP CatheterAbbott

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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