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FDA 510(k)

BRIDGEPOINT MEDICAL CROSSBOSS CATHETER, MODEL M-2000

K-Number: K091841 · 2009-09-02

ApplicantBridgepoint Medical
Decision Date2009-09-02
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BRIDGEPOINT MEDICAL CROSSBOSS CATHETER, MODEL M-2000 is the device name listed in this FDA 510(k) record. The listed applicant is Bridgepoint Medical. It received FDA 510(k) clearance on 2009-09-02 under 510(k) number K091841. 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 CATHETER, MODEL M-2000?

BRIDGEPOINT MEDICAL CROSSBOSS CATHETER, MODEL M-2000 is a medical device that received FDA 510(k) clearance on 2009-09-02. The listed applicant is Bridgepoint Medical. The 510(k) number is K091841.

When did BRIDGEPOINT MEDICAL CROSSBOSS CATHETER, MODEL M-2000 receive FDA 510(k) clearance?

BRIDGEPOINT MEDICAL CROSSBOSS CATHETER, MODEL M-2000 received FDA 510(k) clearance on 2009-09-02, under 510(k) number K091841.

Who is the listed applicant for BRIDGEPOINT MEDICAL CROSSBOSS CATHETER, MODEL M-2000?

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 CATHETER, MODEL M-2000?

The FDA product code for BRIDGEPOINT MEDICAL CROSSBOSS CATHETER, MODEL M-2000 is DQY.

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Other records listing Bridgepoint Medical as applicant

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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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