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FDA 510(k)

MARKSMAN CATHETER, *REFERS TO DIFFERENT CATHETER WORKING LENGHTS, DISTAL SINGLE COILED LENGTHS AND DISTAL SHAFT LENGTHS

K-Number: K111490 · 2011-09-16

ApplicantEv3, Inc.
Decision Date2011-09-16
Product CodeKRA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MARKSMAN CATHETER, *REFERS TO DIFFERENT CATHETER WORKING LENGHTS, DISTAL SINGLE COILED LENGTHS AND DISTAL SHAFT LENGTHS is the device name listed in this FDA 510(k) record. The listed applicant is Ev3, Inc.. It received FDA 510(k) clearance on 2011-09-16 under 510(k) number K111490. The device is classified under product code KRA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MARKSMAN CATHETER, *REFERS TO DIFFERENT CATHETER WORKING LENGHTS, DISTAL SINGLE COILED LENGTHS AND DISTAL SHAFT LENGTHS?

MARKSMAN CATHETER, *REFERS TO DIFFERENT CATHETER WORKING LENGHTS, DISTAL SINGLE COILED LENGTHS AND DISTAL SHAFT LENGTHS is a medical device that received FDA 510(k) clearance on 2011-09-16. The listed applicant is Ev3, Inc.. The 510(k) number is K111490.

When did MARKSMAN CATHETER, *REFERS TO DIFFERENT CATHETER WORKING LENGHTS, DISTAL SINGLE COILED LENGTHS AND DISTAL SHAFT LENGTHS receive FDA 510(k) clearance?

MARKSMAN CATHETER, *REFERS TO DIFFERENT CATHETER WORKING LENGHTS, DISTAL SINGLE COILED LENGTHS AND DISTAL SHAFT LENGTHS received FDA 510(k) clearance on 2011-09-16, under 510(k) number K111490.

Who is the listed applicant for MARKSMAN CATHETER, *REFERS TO DIFFERENT CATHETER WORKING LENGHTS, DISTAL SINGLE COILED LENGTHS AND DISTAL SHAFT LENGTHS?

The FDA 510(k) record lists Ev3, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MARKSMAN CATHETER, *REFERS TO DIFFERENT CATHETER WORKING LENGHTS, DISTAL SINGLE COILED LENGTHS AND DISTAL SHAFT LENGTHS?

The FDA product code for MARKSMAN CATHETER, *REFERS TO DIFFERENT CATHETER WORKING LENGHTS, DISTAL SINGLE COILED LENGTHS AND DISTAL SHAFT LENGTHS is KRA.

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Related Devices (Code: KRA)

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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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