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FDA 510(k)

NC TREK NEO Coronary Dilatation Catheter

K-Number: K220634 · 2022-06-30

ApplicantAbbott Vascular
Decision Date2022-06-30
Product CodeLOX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

NC TREK NEO Coronary Dilatation Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Vascular. It received FDA 510(k) clearance on 2022-06-30 under 510(k) number K220634. The device is classified under product code LOX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NC TREK NEO Coronary Dilatation Catheter?

NC TREK NEO Coronary Dilatation Catheter is a medical device that received FDA 510(k) clearance on 2022-06-30. The listed applicant is Abbott Vascular. The 510(k) number is K220634.

When did NC TREK NEO Coronary Dilatation Catheter receive FDA 510(k) clearance?

NC TREK NEO Coronary Dilatation Catheter received FDA 510(k) clearance on 2022-06-30, under 510(k) number K220634.

Who is the listed applicant for NC TREK NEO Coronary Dilatation Catheter?

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

What is the FDA product code for NC TREK NEO Coronary Dilatation Catheter?

The FDA product code for NC TREK NEO Coronary Dilatation Catheter is LOX.

Related Clinical Trials

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NCT05509296Compare the Effectiveness and Safety of Two Different Kinds of Cutting Balloon in Coronary Artery DiseaseCOMPLETED

Other records listing Abbott Vascular 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.

PMA P110019Coronary drug-eluting stentPMA P960043Device, hemostasis, vascularPMA P040038Stent, carotidPMA P110028STENT, ILIACPMA P110001STENT, RENALPMA P040012Stent, carotid

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Related Devices (Code: LOX)

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.

K261428NC Euphora Rapid Exchange Balloon Dilatation CatheterMedtronic IrelandK261759Euphora Rapid Exchange (RX) Balloon Dilatation CatheterMedtronic IrelandK252116Firefighter™ Pro PTCA Balloon CatheterShanghai MicroPort Medical (Group) Co., Ltd.K254022FLASH Flex™ Aorto-Ostial Angioplasty SystemVerge Medical, Inc.K252295RyureiTerumo CorporationK251970Sprinter Legend Rapid Exchange Balloon Dilatation CatheterMedtronic, Ireland

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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