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FDA 510(k)

SeQuent Neo Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheters

K-Number: K162625 · 2017-06-12

ApplicantB. Braun Interventional Systems, Inc.
Decision Date2017-06-12
Product CodeLOX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SeQuent Neo Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheters is the device name listed in this FDA 510(k) record. The listed applicant is B. Braun Interventional Systems, Inc.. It received FDA 510(k) clearance on 2017-06-12 under 510(k) number K162625. 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 SeQuent Neo Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheters?

SeQuent Neo Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheters is a medical device that received FDA 510(k) clearance on 2017-06-12. The listed applicant is B. Braun Interventional Systems, Inc.. The 510(k) number is K162625.

When did SeQuent Neo Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheters receive FDA 510(k) clearance?

SeQuent Neo Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheters received FDA 510(k) clearance on 2017-06-12, under 510(k) number K162625.

Who is the listed applicant for SeQuent Neo Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheters?

The FDA 510(k) record lists B. Braun Interventional Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SeQuent Neo Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheters?

The FDA product code for SeQuent Neo Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheters 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.

NCT03466151RESOLUTE ONYX China RCT StudyACTIVE_NOT_RECRUITINGNCT03471845RESOLUTE ONYX China Single Arm StudyACTIVE_NOT_RECRUITINGNCT05731700CVT-ISR First in Human Trial for Coronary In-Stent RestenosisCOMPLETEDNCT07783880Investigation to Assess the Effects of Drug-COATED Balloons for Treatment of Plaques Erosions Causing Acute Coronary SyndromesNOT_YET_RECRUITINGNCT04058990Safety 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_RECRUITING

Other records listing B. Braun Interventional Systems, Inc. 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.

K152765VENATECH CONVERTIBLE VENA CAVA FILTER SYSTEM

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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