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FDA 510(k)

Oscar Peripheral Multifunctional Catheter system

K-Number: K214038 · 2022-07-06

ApplicantBiotronik, Inc.
Decision Date2022-07-06
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Oscar Peripheral Multifunctional Catheter system is the device name listed in this FDA 510(k) record. The listed applicant is Biotronik, Inc.. It received FDA 510(k) clearance on 2022-07-06 under 510(k) number K214038. 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 Oscar Peripheral Multifunctional Catheter system?

Oscar Peripheral Multifunctional Catheter system is a medical device that received FDA 510(k) clearance on 2022-07-06. The listed applicant is Biotronik, Inc.. The 510(k) number is K214038.

When did Oscar Peripheral Multifunctional Catheter system receive FDA 510(k) clearance?

Oscar Peripheral Multifunctional Catheter system received FDA 510(k) clearance on 2022-07-06, under 510(k) number K214038.

Who is the listed applicant for Oscar Peripheral Multifunctional Catheter system?

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 Oscar Peripheral Multifunctional Catheter system?

The FDA product code for Oscar Peripheral Multifunctional Catheter system is LIT.

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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.

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.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.

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