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FDA 510(k)

POT PTCA Balloon Dilatation Catheter

K-Number: K230705 · 2023-04-11

ApplicantBrosmed Medical Co., Ltd.
Decision Date2023-04-11
Product CodeLOX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

POT PTCA Balloon Dilatation Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Brosmed Medical Co., Ltd.. It received FDA 510(k) clearance on 2023-04-11 under 510(k) number K230705. 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 POT PTCA Balloon Dilatation Catheter?

POT PTCA Balloon Dilatation Catheter is a medical device that received FDA 510(k) clearance on 2023-04-11. The listed applicant is Brosmed Medical Co., Ltd.. The 510(k) number is K230705.

When did POT PTCA Balloon Dilatation Catheter receive FDA 510(k) clearance?

POT PTCA Balloon Dilatation Catheter received FDA 510(k) clearance on 2023-04-11, under 510(k) number K230705.

Who is the listed applicant for POT PTCA Balloon Dilatation Catheter?

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

What is the FDA product code for POT PTCA Balloon Dilatation Catheter?

The FDA product code for POT PTCA Balloon Dilatation Catheter is LOX.

Related Clinical Trials

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Other records listing Brosmed Medical Co., Ltd. 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.

K243704Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018 PTA Balloon Dilatation Catheter; Parafleet SC 035 PTA Balloon Dilatation CatheterK241478Tri-Wedge PTA Scoring Balloon Dilatation CatheterK212215Tiche PTA Balloon Dilatation CatheterK203390Artimes pro Balloon Dilatation CatheterK160941Castor, Achilles and Hermes NC PTA Balloon Dilatation CatheterK153742Apollo Balloon Dilatation Catheter

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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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