FDA 510(k)

SABER .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter

N.º K: K210626 · 2021-04-23

Fecha de decisión2021-04-23

Código de productoLIT

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

SABER .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Cordis Corporation. It received FDA 510(k) clearance on 2021-04-23 under 510(k) number K210626. The device is classified under product code LIT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the SABER .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter?

SABER .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter is a medical device that received FDA 510(k) clearance on 2021-04-23. The listed applicant is Cordis Corporation. The 510(k) number is K210626.

When did SABER .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter receive FDA 510(k) clearance?

SABER .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter received FDA 510(k) clearance on 2021-04-23, under 510(k) number K210626.

Who is the listed applicant for SABER .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter?

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

What is the FDA product code for SABER .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter?

The FDA product code for SABER .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter is LIT.

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Otros registros que enlistan a Cordis Corporation como solicitante

K220654GUIDA DE CAPTURA DE EMBOLOS ANGIOGUARD XP, GUIDA DE CAPTURA DE EMBOLOS ANGIOGUARD RX K212977SUPER TORQUE MB Angiographic Catheter with Radiopaque markerbands K202167Brite Tip Radianz Guiding Sheath K201377SABERX RADIANZ Percutaneous Transluminal Angioplasty Dilatation Catheter K201333SABER .035 PTA Dilatation Catheter K181592RAIN Sheath Transradial

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Dispositivos relacionados (Código: LIT)

K260416ZYLOX Hippo PTA Balloon Dilatation CatheterZylox Medtech Co., Ltd.K254212NC PTA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd.K260304WAVE PTA Balloon CatheterWAVE Medical AG K252512Catheter Armada™ 14 NC PTAABBOTT MEDICAL K251915Cáteter Amethyst HP PTA OTW 0.035Natec 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.

Fuente oficial

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