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)

DK-PTCA BALLOON CATHETER

K-Number: K123264 · 2013-01-16

ApplicantIntuit Medical, LLC
Decision Date2013-01-16
Product CodeLOX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DK-PTCA BALLOON CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Intuit Medical, LLC. It received FDA 510(k) clearance on 2013-01-16 under 510(k) number K123264. 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 DK-PTCA BALLOON CATHETER?

DK-PTCA BALLOON CATHETER is a medical device that received FDA 510(k) clearance on 2013-01-16. The listed applicant is Intuit Medical, LLC. The 510(k) number is K123264.

When did DK-PTCA BALLOON CATHETER receive FDA 510(k) clearance?

DK-PTCA BALLOON CATHETER received FDA 510(k) clearance on 2013-01-16, under 510(k) number K123264.

Who is the listed applicant for DK-PTCA BALLOON CATHETER?

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

What is the FDA product code for DK-PTCA BALLOON CATHETER?

The FDA product code for DK-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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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.

↑