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FDA 510(k)

Chocolate XD PTCA Balloon Catheter

K-Number: K153682 · 2016-06-23

ApplicantTrireme Medical, LLC
Decision Date2016-06-23
Product CodeLOX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Chocolate XD PTCA Balloon Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Trireme Medical, LLC. It received FDA 510(k) clearance on 2016-06-23 under 510(k) number K153682. 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 Chocolate XD PTCA Balloon Catheter?

Chocolate XD PTCA Balloon Catheter is a medical device that received FDA 510(k) clearance on 2016-06-23. The listed applicant is Trireme Medical, LLC. The 510(k) number is K153682.

When did Chocolate XD PTCA Balloon Catheter receive FDA 510(k) clearance?

Chocolate XD PTCA Balloon Catheter received FDA 510(k) clearance on 2016-06-23, under 510(k) number K153682.

Who is the listed applicant for Chocolate XD PTCA Balloon Catheter?

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

What is the FDA product code for Chocolate XD PTCA Balloon Catheter?

The FDA product code for Chocolate XD PTCA Balloon Catheter is LOX.

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.

NCT04058990Safety and Effectiveness of Agent Paclitaxel-Coated PTCA Balloon Catheter. (AGENT Japan SV)COMPLETEDNCT04647253A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis (ISR)ACTIVE_NOT_RECRUITINGNCT06492174A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis (ISR) - Long Lesion CohortACTIVE_NOT_RECRUITING

Other records listing Trireme 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.

PMA P210039Drug-Eluting Peripheral Transluminal Angioplasty Catheter

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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