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FDA 510(k)

JUDO 1 Guidewire, JUDO 3 Guidewire, JUDO 6 Guidewire

K-Number: K180795 · 2018-04-12

ApplicantBoston Scientific
Decision Date2018-04-12
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

JUDO 1 Guidewire, JUDO 3 Guidewire, JUDO 6 Guidewire is a medical device manufactured by Boston Scientific. It received FDA 510(k) clearance on 2018-04-12 under approval number K180795. 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 JUDO 1 Guidewire, JUDO 3 Guidewire, JUDO 6 Guidewire?

JUDO 1 Guidewire, JUDO 3 Guidewire, JUDO 6 Guidewire is a medical device that received FDA 510(k) clearance on 2018-04-12. It is manufactured by Boston Scientific. The 510(k) number is K180795.

When was JUDO 1 Guidewire, JUDO 3 Guidewire, JUDO 6 Guidewire approved by the FDA?

JUDO 1 Guidewire, JUDO 3 Guidewire, JUDO 6 Guidewire received FDA 510(k) clearance on 2018-04-12, under approval number K180795.

What company makes JUDO 1 Guidewire, JUDO 3 Guidewire, JUDO 6 Guidewire?

JUDO 1 Guidewire, JUDO 3 Guidewire, JUDO 6 Guidewire is manufactured by Boston Scientific.

What is the FDA product code for JUDO 1 Guidewire, JUDO 3 Guidewire, JUDO 6 Guidewire?

The FDA product code for JUDO 1 Guidewire, JUDO 3 Guidewire, JUDO 6 Guidewire is DQX.

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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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