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FDA 510(k)

Passeo-35 Xeo Peripheral Dilatation Catheter

K-Number: K222065 · 2023-02-16

ApplicantBiotronik, Inc.
Decision Date2023-02-16
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Passeo-35 Xeo Peripheral Dilatation Catheter is a medical device manufactured by Biotronik, Inc.. It received FDA 510(k) clearance on 2023-02-16 under approval 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. It is manufactured by Biotronik, Inc.. The 510(k) number is K222065.

When was Passeo-35 Xeo Peripheral Dilatation Catheter approved by the FDA?

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

What company makes Passeo-35 Xeo Peripheral Dilatation Catheter?

Passeo-35 Xeo Peripheral Dilatation Catheter is manufactured by Biotronik, Inc..

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

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Other Devices by Biotronik, Inc.

K160985Pantera Pro K152995BioMonitor 2-AF, BioMonitor 2-S K171514BioMonitor 2-AF, BioMonitor 2-S, FIT - Fast Insert Tool 1 + 2, Set K170628BioMonitor 2-AF, BioMonitor 2-S K163660Pantera LEO K183265Selectra Catheters, Selectra Accessory Kit

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Related Devices (Code: LIT)

K160941Castor, Achilles and Hermes NC PTA Balloon Dilatation CatheterBrosmed Medical Co., Ltd. K162316Pirouette 014Arravasc, Ltd. K162350Coyote Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter, Express SD Biliary Monorail Premounted Stent System, Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail Dilatation Catheter, Sterling Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter, Ultra-Soft SV Monorail Balloon Dilatation Catheter 0.018Boston Scientific Corporation K161427Pirouette 035Arravasc Limited K160256Polux , Minerva and Atropos PTA Balloon Dilatation CatheterBrosmed Medical Co., Ltd. K160004Crosstella OTWKANEKA Corporation

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.

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