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FDA 510(k)

MANTARAY GUIDEWIRE MODEL M-6000, M-6001, M-6002, M-6003

K-Number: K111488 · 2011-06-30

ApplicantBridgepoint Medical
Decision Date2011-06-30
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MANTARAY GUIDEWIRE MODEL M-6000, M-6001, M-6002, M-6003 is the device name listed in this FDA 510(k) record. The listed applicant is Bridgepoint Medical. It received FDA 510(k) clearance on 2011-06-30 under 510(k) number K111488. 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 MANTARAY GUIDEWIRE MODEL M-6000, M-6001, M-6002, M-6003?

MANTARAY GUIDEWIRE MODEL M-6000, M-6001, M-6002, M-6003 is a medical device that received FDA 510(k) clearance on 2011-06-30. The listed applicant is Bridgepoint Medical. The 510(k) number is K111488.

When did MANTARAY GUIDEWIRE MODEL M-6000, M-6001, M-6002, M-6003 receive FDA 510(k) clearance?

MANTARAY GUIDEWIRE MODEL M-6000, M-6001, M-6002, M-6003 received FDA 510(k) clearance on 2011-06-30, under 510(k) number K111488.

Who is the listed applicant for MANTARAY GUIDEWIRE MODEL M-6000, M-6001, M-6002, M-6003?

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 MANTARAY GUIDEWIRE MODEL M-6000, M-6001, M-6002, M-6003?

The FDA product code for MANTARAY GUIDEWIRE MODEL M-6000, M-6001, M-6002, M-6003 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.

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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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