Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Map-it Diagnostic Mapping Catheters

K-Number: K160390 · 2016-04-11

ApplicantAccess Point Technologies Ep, Inc.
Decision Date2016-04-11
Product CodeDRF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Map-it Diagnostic Mapping Catheters is the device name listed in this FDA 510(k) record. The listed applicant is Access Point Technologies Ep, Inc.. It received FDA 510(k) clearance on 2016-04-11 under 510(k) number K160390. 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 Map-it Diagnostic Mapping Catheters?

Map-it Diagnostic Mapping Catheters is a medical device that received FDA 510(k) clearance on 2016-04-11. The listed applicant is Access Point Technologies Ep, Inc.. The 510(k) number is K160390.

When did Map-it Diagnostic Mapping Catheters receive FDA 510(k) clearance?

Map-it Diagnostic Mapping Catheters received FDA 510(k) clearance on 2016-04-11, under 510(k) number K160390.

Who is the listed applicant for Map-it Diagnostic Mapping Catheters?

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

What is the FDA product code for Map-it Diagnostic Mapping Catheters?

The FDA product code for Map-it Diagnostic Mapping 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.

NCT07759427Using Non-Invasive Mapping To Eliminate Structural Heart Disease Ventricular TachycardiaRECRUITING

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.

↑