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FDA 510(k)

STINGRAY ORIENTING BALLOON CATHETER

K-Number: K101591 · 2010-08-06

ApplicantBridgepoint Medical
Decision Date2010-08-06
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

STINGRAY ORIENTING BALLOON 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 2010-08-06 under 510(k) number K101591. 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 STINGRAY ORIENTING BALLOON CATHETER?

STINGRAY ORIENTING BALLOON CATHETER is a medical device that received FDA 510(k) clearance on 2010-08-06. The listed applicant is Bridgepoint Medical. The 510(k) number is K101591.

When did STINGRAY ORIENTING BALLOON CATHETER receive FDA 510(k) clearance?

STINGRAY ORIENTING BALLOON CATHETER received FDA 510(k) clearance on 2010-08-06, under 510(k) number K101591.

Who is the listed applicant for STINGRAY ORIENTING BALLOON 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 STINGRAY ORIENTING BALLOON CATHETER?

The FDA product code for STINGRAY ORIENTING BALLOON 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.

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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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