FDA 510(k)

MultiCath, AcQRate Dx Fixed Curve Catheter

K-Number: K201445 · 2021-09-02

Decision Date2021-09-02

Product CodeDRF

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

MultiCath, AcQRate Dx Fixed Curve 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 2021-09-02 under 510(k) number K201445. The device is classified under product code DRF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MultiCath, AcQRate Dx Fixed Curve Catheter?

MultiCath, AcQRate Dx Fixed Curve Catheter is a medical device that received FDA 510(k) clearance on 2021-09-02. The listed applicant is Biotronik, Inc.. The 510(k) number is K201445.

When did MultiCath, AcQRate Dx Fixed Curve Catheter receive FDA 510(k) clearance?

MultiCath, AcQRate Dx Fixed Curve Catheter received FDA 510(k) clearance on 2021-09-02, under 510(k) number K201445.

Who is the listed applicant for MultiCath, AcQRate Dx Fixed Curve 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 MultiCath, AcQRate Dx Fixed Curve Catheter?

The FDA product code for MultiCath, AcQRate Dx Fixed Curve Catheter is DRF.

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

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: DRF)

K252794Vision-MR™ Diagnostic CatheterImricor Medical Systems, Inc.K250590MAGiC Sweep™ EP Mapping CatheterStereotaxis, Inc.K250310VIKING™ Fixed Curve Diagnostic CatheterBoston Scientific Corporation PMA P990025CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDINGBiosense Webster, Inc.K240366EP•XT™ Unidirectional Steerable Diagnostic Catheter; Dynamic Tip™ Unidirectional Steerable Diagnostic Catheter; Dynamic XT™ Unidirectional Steerable Diagnostic CatheterBoston Scientific Corporation K233900Nordica PV Cryo Mapping CatheterSynaptic Medical 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.