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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 a medical device manufactured by Access Point Technologies Ep, Inc.. It received FDA 510(k) clearance on 2016-04-11 under approval 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. It is manufactured by Access Point Technologies Ep, Inc.. The 510(k) number is K160390.

When was Map-it Diagnostic Mapping Catheters approved by the FDA?

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

What company makes Map-it Diagnostic Mapping Catheters?

Map-it Diagnostic Mapping Catheters is manufactured by Access Point Technologies Ep, Inc..

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

The FDA product code for Map-it Diagnostic Mapping Catheters is DRF.

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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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