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FDA 510(k)

PLATINUM SERIES EP DIAGNOSTIC CATHETERS

K-Number: K953185 · 1996-04-15

ApplicantMedtronic Cardiorhythm
Decision Date1996-04-15
Product CodeDRF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PLATINUM SERIES EP DIAGNOSTIC CATHETERS is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Cardiorhythm. It received FDA 510(k) clearance on 1996-04-15 under 510(k) number K953185. 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 PLATINUM SERIES EP DIAGNOSTIC CATHETERS?

PLATINUM SERIES EP DIAGNOSTIC CATHETERS is a medical device that received FDA 510(k) clearance on 1996-04-15. The listed applicant is Medtronic Cardiorhythm. The 510(k) number is K953185.

When did PLATINUM SERIES EP DIAGNOSTIC CATHETERS receive FDA 510(k) clearance?

PLATINUM SERIES EP DIAGNOSTIC CATHETERS received FDA 510(k) clearance on 1996-04-15, under 510(k) number K953185.

Who is the listed applicant for PLATINUM SERIES EP DIAGNOSTIC CATHETERS?

The FDA 510(k) record lists Medtronic Cardiorhythm as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PLATINUM SERIES EP DIAGNOSTIC CATHETERS?

The FDA product code for PLATINUM SERIES EP DIAGNOSTIC CATHETERS 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 Medtronic Cardiorhythm 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.

K981642STABLEMAPR STEERABLE INTRACARDIAC CATHETERSK964272PERFORMR SERIES EP DIAGNOSTIC CATHETERSK951347MARINR SERIES EP DIAGNOSTI CATHETERSK931794MARINR SERIES EP DIAGNOSTIC CATHETERS

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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