FDA 510(k)

CoreDx™ Pulmonary Mini-Forceps

K-Number: K183085 · 2019-03-08

Decision Date2019-03-08

Product CodeEOQ

Advisory CommitteeEN

DecisionSubstantially Equivalent

Device Summary

CoreDx™ Pulmonary Mini-Forceps is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corporation. It received FDA 510(k) clearance on 2019-03-08 under 510(k) number K183085. The device is classified under product code EOQ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CoreDx™ Pulmonary Mini-Forceps?

CoreDx™ Pulmonary Mini-Forceps is a medical device that received FDA 510(k) clearance on 2019-03-08. The listed applicant is Boston Scientific Corporation. The 510(k) number is K183085.

When did CoreDx™ Pulmonary Mini-Forceps receive FDA 510(k) clearance?

CoreDx™ Pulmonary Mini-Forceps received FDA 510(k) clearance on 2019-03-08, under 510(k) number K183085.

Who is the listed applicant for CoreDx™ Pulmonary Mini-Forceps?

The FDA 510(k) record lists Boston Scientific Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CoreDx™ Pulmonary Mini-Forceps?

The FDA product code for CoreDx™ Pulmonary Mini-Forceps is EOQ.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.