FDA 510(k)

MARKSMANN CATHETER

K-Number: K091559 · 2009-09-18

ApplicantChestnut Medical Technologies, Inc.

Decision Date2009-09-18

Product CodeKRA

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

MARKSMANN CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Chestnut Medical Technologies, Inc.. It received FDA 510(k) clearance on 2009-09-18 under 510(k) number K091559. 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 MARKSMANN CATHETER?

MARKSMANN CATHETER is a medical device that received FDA 510(k) clearance on 2009-09-18. The listed applicant is Chestnut Medical Technologies, Inc.. The 510(k) number is K091559.

When did MARKSMANN CATHETER receive FDA 510(k) clearance?

MARKSMANN CATHETER received FDA 510(k) clearance on 2009-09-18, under 510(k) number K091559.

Who is the listed applicant for MARKSMANN CATHETER?

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

What is the FDA product code for MARKSMANN CATHETER?

The FDA product code for MARKSMANN CATHETER is KRA.

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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.