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FDA 510(k)

CRE RX Biliary Balloon Dilatation Catheter

K-Number: K172520 · 2017-10-04

Decision Date2017-10-04
Product CodeFGE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CRE RX Biliary 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 2017-10-04 under 510(k) number K172520. The device is classified under product code FGE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CRE RX Biliary Balloon Dilatation Catheter?

CRE RX Biliary Balloon Dilatation Catheter is a medical device that received FDA 510(k) clearance on 2017-10-04. The listed applicant is Boston Scientific Corporation. The 510(k) number is K172520.

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

CRE RX Biliary Balloon Dilatation Catheter received FDA 510(k) clearance on 2017-10-04, under 510(k) number K172520.

Who is the listed applicant for CRE RX Biliary 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 RX Biliary Balloon Dilatation Catheter?

The FDA product code for CRE RX Biliary Balloon Dilatation Catheter is FGE.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Other records listing Boston Scientific Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: FGE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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.