Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Boosting Catheter

K-Number: K160561 · 2016-11-02

ApplicantQxmedical, LLC
Decision Date2016-11-02
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Boosting Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Qxmedical, LLC. It received FDA 510(k) clearance on 2016-11-02 under 510(k) number K160561. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Boosting Catheter?

Boosting Catheter is a medical device that received FDA 510(k) clearance on 2016-11-02. The listed applicant is Qxmedical, LLC. The 510(k) number is K160561.

When did Boosting Catheter receive FDA 510(k) clearance?

Boosting Catheter received FDA 510(k) clearance on 2016-11-02, under 510(k) number K160561.

Who is the listed applicant for Boosting Catheter?

The FDA 510(k) record lists Qxmedical, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Boosting Catheter?

The FDA product code for Boosting Catheter is DQY.

Other records listing Qxmedical, LLC 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.

K200317Support CatheterK183679Occlusion Balloon Catheter

Related Devices (Code: DQY)

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.

K262240SSPC NXT Delivery CatheterCenterPoint Systems, LLCK261766CPS Locator 3D Plus Delivery CatheterCenterPoint Systems, LLCK261825Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP CatheterAbbottK261631Amplatzer TorqVue Exchange SystemAbbott MedicalK260289Perfect-O Ostial Positioning CatheterBalosmark, Inc.K260993Amplatzer TorqVue Delivery SystemAbbott

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.

↑