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FDA 510(k)

CRE Pulmonary Balloon Dilatation Catheter

K-Number: K170759 · 2017-06-23

ApplicantBoston Scientific Corporation
Decision Date2017-06-23
Product CodeKTI
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

CRE Pulmonary Balloon Dilatation Catheter is a medical device manufactured by Boston Scientific Corporation. It received FDA 510(k) clearance on 2017-06-23 under approval number K170759. The device is classified under product code KTI. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CRE Pulmonary Balloon Dilatation Catheter?

CRE Pulmonary Balloon Dilatation Catheter is a medical device that received FDA 510(k) clearance on 2017-06-23. It is manufactured by Boston Scientific Corporation. The 510(k) number is K170759.

When was CRE Pulmonary Balloon Dilatation Catheter approved by the FDA?

CRE Pulmonary Balloon Dilatation Catheter received FDA 510(k) clearance on 2017-06-23, under approval number K170759.

What company makes CRE Pulmonary Balloon Dilatation Catheter?

CRE Pulmonary Balloon Dilatation Catheter is manufactured by Boston Scientific Corporation.

What is the FDA product code for CRE Pulmonary Balloon Dilatation Catheter?

The FDA product code for CRE Pulmonary Balloon Dilatation Catheter is KTI.

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Related Devices (Code: KTI)

K161392Elation Pulmonary Balloon DilationMerit Medical Systems, Inc. K153484Dillard Airway Dilatation SystemIntuit Medical Products, LLC K152922ViziShot FLEXSpiration, Inc. K171232PeriView FLEXOlympus Surgical Technologies America K163469ViziShot 2 FLEXOlympus Surgical Technologies America K181193PeriView FLEXOlympus Surgical Technologies America

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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