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FDA 510(k)

BRIDGEPOINT MEDICAL STINGRAY DEVICE AND ACCESSORIES

K-Number: K080987 · 2009-02-06

ApplicantBridgepoint Medical
Decision Date2009-02-06
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BRIDGEPOINT MEDICAL STINGRAY DEVICE AND ACCESSORIES is the device name listed in this FDA 510(k) record. The listed applicant is Bridgepoint Medical. It received FDA 510(k) clearance on 2009-02-06 under 510(k) number K080987. 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 STINGRAY DEVICE AND ACCESSORIES?

BRIDGEPOINT MEDICAL STINGRAY DEVICE AND ACCESSORIES is a medical device that received FDA 510(k) clearance on 2009-02-06. The listed applicant is Bridgepoint Medical. The 510(k) number is K080987.

When did BRIDGEPOINT MEDICAL STINGRAY DEVICE AND ACCESSORIES receive FDA 510(k) clearance?

BRIDGEPOINT MEDICAL STINGRAY DEVICE AND ACCESSORIES received FDA 510(k) clearance on 2009-02-06, under 510(k) number K080987.

Who is the listed applicant for BRIDGEPOINT MEDICAL STINGRAY DEVICE AND ACCESSORIES?

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 STINGRAY DEVICE AND ACCESSORIES?

The FDA product code for BRIDGEPOINT MEDICAL STINGRAY DEVICE AND ACCESSORIES 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.

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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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