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FDA 510(k)

2 CM PERIPHERAL CUTTING BALOON

K-Number: K041993 · 2004-08-16

ApplicantBoston Scientific Ivt
Decision Date2004-08-16
Product CodePNO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

2 CM PERIPHERAL CUTTING BALOON is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Ivt. It received FDA 510(k) clearance on 2004-08-16 under 510(k) number K041993. The device is classified under product code PNO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 2 CM PERIPHERAL CUTTING BALOON?

2 CM PERIPHERAL CUTTING BALOON is a medical device that received FDA 510(k) clearance on 2004-08-16. The listed applicant is Boston Scientific Ivt. The 510(k) number is K041993.

When did 2 CM PERIPHERAL CUTTING BALOON receive FDA 510(k) clearance?

2 CM PERIPHERAL CUTTING BALOON received FDA 510(k) clearance on 2004-08-16, under 510(k) number K041993.

Who is the listed applicant for 2 CM PERIPHERAL CUTTING BALOON?

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

What is the FDA product code for 2 CM PERIPHERAL CUTTING BALOON?

The FDA product code for 2 CM PERIPHERAL CUTTING BALOON is PNO.

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.

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Other records listing Boston Scientific Ivt 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.

K051254PERIPHERAL CUTTING BALLOON

Related Devices (Code: PNO)

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.

K261778JADE SCORE PTA Scoring Balloon Dilatation CatheterOrbusNeich Medical (Shenzhen) Co., Ltd.K260012UltraScore™ Focused Force PTA BalloonBard Peripheral Vascular, Inc.K243944Aperta NSE PTA Balloon Dilatation CatheterGoodman Co., Ltd.K242254D·Kutting™ LL Peripheral Scoring Balloon Dilatation CatheterDk Medical Technology Co., Ltd.K241478Tri-Wedge PTA Scoring Balloon Dilatation CatheterBrosmed Medical Co., Ltd.K232258XO Constrain™ Percutaneous Transluminal Angioplasty Constraining CatheterTransit Scientific, LLC

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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