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FDA 510(k)

ADMIRAL XTREME PTA BALLOON DILATATION CATHETER

K-Number: K100921 · 2010-04-30

ApplicantInvatec S.P.A.
Decision Date2010-04-30
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ADMIRAL XTREME PTA BALLOON DILATATION CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Invatec S.P.A.. It received FDA 510(k) clearance on 2010-04-30 under 510(k) number K100921. The device is classified under product code LIT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADMIRAL XTREME PTA BALLOON DILATATION CATHETER?

ADMIRAL XTREME PTA BALLOON DILATATION CATHETER is a medical device that received FDA 510(k) clearance on 2010-04-30. The listed applicant is Invatec S.P.A.. The 510(k) number is K100921.

When did ADMIRAL XTREME PTA BALLOON DILATATION CATHETER receive FDA 510(k) clearance?

ADMIRAL XTREME PTA BALLOON DILATATION CATHETER received FDA 510(k) clearance on 2010-04-30, under 510(k) number K100921.

Who is the listed applicant for ADMIRAL XTREME PTA BALLOON DILATATION CATHETER?

The FDA 510(k) record lists Invatec S.P.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ADMIRAL XTREME PTA BALLOON DILATATION CATHETER?

The FDA product code for ADMIRAL XTREME PTA BALLOON DILATATION CATHETER is LIT.

Related Clinical Trials

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Other records listing Invatec S.P.A. 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.

K092352SCUBA BILIARY STENT SYSTEMK092361REEF HP 0.035 OTW PTA BALLOON DILATATION CATHETERK092177MO.MA ULTRA PROXIMAL CEREBRAL PROTECTION DEVICE, MODEL MUS0130069X6

Related Devices (Code: LIT)

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.

K260416ZYLOX Hippo PTA Balloon Dilatation CatheterZylox Medtech Co., Ltd.K254212NC PTA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd.K260304WAVE PTA Balloon CatheterWAVE Medical AGK252512Armada™ 14 NC PTA CatheterABBOTT MEDICALK251915Amethyst HP PTA OTW 0.035 CatheterNatec Medical , Ltd.K250706Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Catheters; Passeo-14 Peripheral Dilatation Catheter; Oscar Peripheral Multifunctional Catheter System; Pantera Pro Percutaneous Transluminal Coronary Angioplasty Catheter; Pantera LEO Percutaneous Transluminal Coronary Angioplasty (PTCA) CatheterBiotronik, Inc.

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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