FDA 510(k)

Passeo-35 Xeo Peripheral Dilatation Catheter

K-Number: K222065 · 2023-02-16

Decision Date2023-02-16

Product CodeLIT

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Passeo-35 Xeo Peripheral Dilatation Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Biotronik, Inc.. It received FDA 510(k) clearance on 2023-02-16 under 510(k) number K222065. 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 Passeo-35 Xeo Peripheral Dilatation Catheter?

Passeo-35 Xeo Peripheral Dilatation Catheter is a medical device that received FDA 510(k) clearance on 2023-02-16. The listed applicant is Biotronik, Inc.. The 510(k) number is K222065.

When did Passeo-35 Xeo Peripheral Dilatation Catheter receive FDA 510(k) clearance?

Passeo-35 Xeo Peripheral Dilatation Catheter received FDA 510(k) clearance on 2023-02-16, under 510(k) number K222065.

Who is the listed applicant for Passeo-35 Xeo Peripheral Dilatation Catheter?

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

What is the FDA product code for Passeo-35 Xeo Peripheral Dilatation Catheter?

The FDA product code for Passeo-35 Xeo Peripheral Dilatation Catheter is LIT.

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.

NCT05540223Safety and Clinical Performance of the Freesolve Resorbable Magnesium Scaffold SystemACTIVE_NOT_RECRUITING NCT06540079BIOTRONIK Conduction System Pacing With the Solia Lead - Solia CSP SCOMPLETED NCT07091682Safety and Clinical Performance of the Freesolve Resorbable Magnesium Scaffold System in the Treatment of Subjects With Long de Novo LesionsRECRUITING NCT07118358BIOTRONIK Investigation of the LivIQ Leadless Pacemaker SystemRECRUITING NCT06832631VITUS Post-Market RegistryACTIVE_NOT_RECRUITING

Other records listing Biotronik, Inc. as applicant

PMA P170030Coronary drug-eluting stent PMA P980023Implantable cardioverter defibrillator (non-CRT)PMA P950037implantable pacemaker Pulse-generator PMA P050023DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER PMA P000009DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER PMA P160025STENT, SUPERFICIAL FEMORAL ARTERY

View all 33 devices →

Related Devices (Code: LIT)

K260304WAVE PTA Balloon CatheterWAVE Medical AG K252512Armada™ 14 NC PTA CatheterABBOTT MEDICAL K251915Amethyst 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.K243704Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018 PTA Balloon Dilatation Catheter; Parafleet SC 035 PTA Balloon Dilatation CatheterBrosmed Medical Co., Ltd.K241040Amethyst HP PTA OTW 0.035 CatheterNatec Medical , Ltd.

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.