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FDA 510(k)

STABLEMAPR STEERABLE INTRACARDIAC CATHETERS

K-Number: K981642 · 1998-08-05

ApplicantMedtronic Cardiorhythm
Decision Date1998-08-05
Product CodeDRF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

STABLEMAPR STEERABLE INTRACARDIAC 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 1998-08-05 under 510(k) number K981642. 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 STABLEMAPR STEERABLE INTRACARDIAC CATHETERS?

STABLEMAPR STEERABLE INTRACARDIAC CATHETERS is a medical device that received FDA 510(k) clearance on 1998-08-05. The listed applicant is Medtronic Cardiorhythm. The 510(k) number is K981642.

When did STABLEMAPR STEERABLE INTRACARDIAC CATHETERS receive FDA 510(k) clearance?

STABLEMAPR STEERABLE INTRACARDIAC CATHETERS received FDA 510(k) clearance on 1998-08-05, under 510(k) number K981642.

Who is the listed applicant for STABLEMAPR STEERABLE INTRACARDIAC 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 STABLEMAPR STEERABLE INTRACARDIAC CATHETERS?

The FDA product code for STABLEMAPR STEERABLE INTRACARDIAC 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.

K964272PERFORMR SERIES EP DIAGNOSTIC CATHETERSK953185PLATINUM 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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