FDA 510(k)

CRE Pulmonary Balloon Dilatation Catheter

K-Number: K170759 · 2017-06-23

Decision Date2017-06-23

Product CodeKTI

Advisory CommitteeEN

DecisionSubstantially Equivalent

Device Summary

CRE Pulmonary Balloon Dilatation Catheter 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 2017-06-23 under 510(k) 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. The listed applicant is Boston Scientific Corporation. The 510(k) number is K170759.

When did CRE Pulmonary Balloon Dilatation Catheter receive FDA 510(k) clearance?

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

Who is the listed applicant for CRE Pulmonary Balloon Dilatation Catheter?

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 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)

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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.