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FDA 510(k)

Achieve Advance Mapping Catheter

K-Number: K162892 · 2016-11-15

ApplicantMedtronic, Inc.
Decision Date2016-11-15
Product CodeDRF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Achieve Advance Mapping Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic, Inc.. It received FDA 510(k) clearance on 2016-11-15 under 510(k) number K162892. 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 Advance Mapping Catheter?

Achieve Advance Mapping Catheter is a medical device that received FDA 510(k) clearance on 2016-11-15. The listed applicant is Medtronic, Inc.. The 510(k) number is K162892.

When did Achieve Advance Mapping Catheter receive FDA 510(k) clearance?

Achieve Advance Mapping Catheter received FDA 510(k) clearance on 2016-11-15, under 510(k) number K162892.

Who is the listed applicant for Achieve Advance Mapping Catheter?

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

What is the FDA product code for Achieve Advance Mapping Catheter?

The FDA product code for Achieve Advance Mapping Catheter is DRF.

Related Clinical Trials

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NCT07005232Lead Evaluation for Defibrillation and Reliability Post Approval StudyENROLLING_BY_INVITATION

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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 CorporationPMA 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 CorporationK233900Nordica 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.

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