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FDA 510(k)

087 Balloon Guide Catheter System

K-Number: K192525 · 2019-10-31

ApplicantQ'Apel Medical, LLC
Decision Date2019-10-31
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

087 Balloon Guide Catheter System is the device name listed in this FDA 510(k) record. The listed applicant is Q'Apel Medical, LLC. It received FDA 510(k) clearance on 2019-10-31 under 510(k) number K192525. 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 087 Balloon Guide Catheter System?

087 Balloon Guide Catheter System is a medical device that received FDA 510(k) clearance on 2019-10-31. The listed applicant is Q'Apel Medical, LLC. The 510(k) number is K192525.

When did 087 Balloon Guide Catheter System receive FDA 510(k) clearance?

087 Balloon Guide Catheter System received FDA 510(k) clearance on 2019-10-31, under 510(k) number K192525.

Who is the listed applicant for 087 Balloon Guide Catheter System?

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

What is the FDA product code for 087 Balloon Guide Catheter System?

The FDA product code for 087 Balloon Guide Catheter System is DQY.

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.

NCT07247864Balloon Guide Catheter Combined With Filter Protection for Carotid Artery StentingRECRUITINGNCT07576790Evaluation of Balloon Guide Catheter as Proximal Protection During Carotid Artery Stenting (EMBO-PROTECT)NOT_YET_RECRUITINGNCT07678164A Randomized Trial of Carotid Artery Stenting With Balloon Guide CatheterNOT_YET_RECRUITING

Other records listing Q'Apel Medical, 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.

K254276Lynx Aspiration Catheter SystemK240746Neurovascular Access System FamilyK222786072 Aspiration SystemK230322SelectFlex Neurovascular Access System FamilyK211893SelectFlex Neurovascular Access System FamilyK191664SelectFlex 072 Neurovascular Access System

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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.

K260559NHanceITIMDS Operation B.V.K262392APRO 35 Swift CatheterAlembic, LLCK262240SSPC NXT Delivery CatheterCenterPoint Systems, LLCK261766CPS Locator 3D Plus Delivery CatheterCenterPoint Systems, LLCK261825Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP CatheterAbbottK261631Amplatzer TorqVue Exchange SystemAbbott Medical

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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