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FDA 510(k)

BIGBOSS CATHETERS MANTATAY CATHETER MANTARAY GUIDEWIRES

K-Number: K120533 · 2012-05-22

ApplicantBridgepoint Medical
Decision Date2012-05-22
Product CodePDU
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BIGBOSS CATHETERS MANTATAY CATHETER MANTARAY GUIDEWIRES is the device name listed in this FDA 510(k) record. The listed applicant is Bridgepoint Medical. It received FDA 510(k) clearance on 2012-05-22 under 510(k) number K120533. The device is classified under product code PDU. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIGBOSS CATHETERS MANTATAY CATHETER MANTARAY GUIDEWIRES?

BIGBOSS CATHETERS MANTATAY CATHETER MANTARAY GUIDEWIRES is a medical device that received FDA 510(k) clearance on 2012-05-22. The listed applicant is Bridgepoint Medical. The 510(k) number is K120533.

When did BIGBOSS CATHETERS MANTATAY CATHETER MANTARAY GUIDEWIRES receive FDA 510(k) clearance?

BIGBOSS CATHETERS MANTATAY CATHETER MANTARAY GUIDEWIRES received FDA 510(k) clearance on 2012-05-22, under 510(k) number K120533.

Who is the listed applicant for BIGBOSS CATHETERS MANTATAY CATHETER MANTARAY GUIDEWIRES?

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 BIGBOSS CATHETERS MANTATAY CATHETER MANTARAY GUIDEWIRES?

The FDA product code for BIGBOSS CATHETERS MANTATAY CATHETER MANTARAY GUIDEWIRES is PDU.

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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 GUIDEWIRESK120881MANTARAY GUIDEWIRESK120129MANTARAY CATHETERK113589BIGBOSS CATHETERK111963BRIDGEPOINT MEDICAL MANTARAY(TM) CATHETER

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Related Devices (Code: PDU)

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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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