Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Oscar Peripheral Multifunctional Catheter system

K-Number: K241711 · 2024-07-11

ApplicantBiotronik, Inc.
Decision Date2024-07-11
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 2024-07-11 under 510(k) number K241711. 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 2024-07-11. The listed applicant is Biotronik, Inc.. The 510(k) number is K241711.

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

Oscar Peripheral Multifunctional Catheter system received FDA 510(k) clearance on 2024-07-11, under 510(k) number K241711.

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.

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_RECRUITINGNCT06540079BIOTRONIK Conduction System Pacing With the Solia Lead - Solia CSP SCOMPLETEDNCT07091682Safety and Clinical Performance of the Freesolve Resorbable Magnesium Scaffold System in the Treatment of Subjects With Long de Novo LesionsRECRUITINGNCT07118358BIOTRONIK Investigation of the LivIQ Leadless Pacemaker SystemRECRUITING

Other records listing Biotronik, Inc. 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.

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

View all 33 devices →

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.

↑