Cleared Traditional

K091559 - MARKSMANN CATHETER

K091559 is an FDA 510(k) clearance for MARKSMANN CATHETER, manufactured by Chestnut Medical Technologies, Inc.. The device is a Class 2 Cardiovascular device with product code KRA cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K091559 · Chestnut Medical Technologies, Inc. · Cardiovascular device
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Sep 2009
Decision
113d
Days
Class 2
Risk

K091559 is an FDA 510(k) clearance for the MARKSMANN CATHETER. Classified as Catheter, Continuous Flush (product code KRA), Class II - Special Controls.

Submitted by Chestnut Medical Technologies, Inc. (Menlo Park, US). The FDA issued a Cleared decision on September 18, 2009 after a review of 113 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1210 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Chestnut Medical Technologies, Inc. devices

FDA 510(k) Submission Details - K091559

510(k) Number K091559 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 2009
Decision Date September 18, 2009
Days to Decision 113 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 125d · This submission: 113d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KRA Device Classification - Class 2, Special Controls

Product Code KRA Catheter, Continuous Flush
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1210
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - KRA Catheter, Continuous Flush

All 137
Devices cleared under the same product code (KRA) and FDA review panel - the closest regulatory comparables to K091559.
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MERIT MICROCATHETER
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