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FDA 510(k)

ACHIEVE MAPPING CATHETER AND ELECTRICAL CABLE

K-Number: K102588 · 2011-03-18

ApplicantMedtronic Ablation Frontiers, LLC
Decision Date2011-03-18
Product CodeDRF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ACHIEVE MAPPING CATHETER AND ELECTRICAL CABLE is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Ablation Frontiers, LLC. It received FDA 510(k) clearance on 2011-03-18 under 510(k) number K102588. 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 ACHIEVE MAPPING CATHETER AND ELECTRICAL CABLE?

ACHIEVE MAPPING CATHETER AND ELECTRICAL CABLE is a medical device that received FDA 510(k) clearance on 2011-03-18. The listed applicant is Medtronic Ablation Frontiers, LLC. The 510(k) number is K102588.

When did ACHIEVE MAPPING CATHETER AND ELECTRICAL CABLE receive FDA 510(k) clearance?

ACHIEVE MAPPING CATHETER AND ELECTRICAL CABLE received FDA 510(k) clearance on 2011-03-18, under 510(k) number K102588.

Who is the listed applicant for ACHIEVE MAPPING CATHETER AND ELECTRICAL CABLE?

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

What is the FDA product code for ACHIEVE MAPPING CATHETER AND ELECTRICAL CABLE?

The FDA product code for ACHIEVE MAPPING CATHETER AND ELECTRICAL CABLE is DRF.

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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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