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FDA 510(k)

GYRO TIP EP CATHETER

K-Number: K955847 · 1997-01-29

ApplicantCardiac Assist Devices, Inc.
Decision Date1997-01-29
Product CodeDRF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

GYRO TIP EP CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Cardiac Assist Devices, Inc.. It received FDA 510(k) clearance on 1997-01-29 under 510(k) number K955847. 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 GYRO TIP EP CATHETER?

GYRO TIP EP CATHETER is a medical device that received FDA 510(k) clearance on 1997-01-29. The listed applicant is Cardiac Assist Devices, Inc.. The 510(k) number is K955847.

When did GYRO TIP EP CATHETER receive FDA 510(k) clearance?

GYRO TIP EP CATHETER received FDA 510(k) clearance on 1997-01-29, under 510(k) number K955847.

Who is the listed applicant for GYRO TIP EP CATHETER?

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

What is the FDA product code for GYRO TIP EP CATHETER?

The FDA product code for GYRO TIP EP 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Cardiac Assist Devices, 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.

K012520GYRO-TIP LARIAT DEFLECTABLE LOOP MAPPING CATHETER, MODEL GTL-20EK960849MAGNO ALARM

Related Devices (Code: DRF)

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.

K252794Vision-MR™ Diagnostic CatheterImricor Medical Systems, Inc.K250590MAGiC Sweep™ EP Mapping CatheterStereotaxis, Inc.K250310VIKING™ Fixed Curve Diagnostic CatheterBoston Scientific CorporationK240366EP•XT™ Unidirectional Steerable Diagnostic Catheter; Dynamic Tip™ Unidirectional Steerable Diagnostic Catheter; Dynamic XT™ Unidirectional Steerable Diagnostic CatheterBoston Scientific CorporationK233900Nordica PV Cryo Mapping CatheterSynaptic Medical CorporationK233397Cosine-10TM Diagnostic CatheterMedtronic, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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