Cleared Special

K202049 - Python Catheter/Over-the-Wire Latis Graft Cleaning Catheter (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K202049 · Applied Medical Resources Corporation · Cardiovascular device
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Sep 2021
Decision
410d
Days
Class 2
Risk

K202049 is an FDA 510(k) clearance for the Python Catheter/Over-the-Wire Latis Graft Cleaning Catheter. Classified as Catheter, Embolectomy (product code DXE), Class II - Special Controls.

Submitted by Applied Medical Resources Corporation (Rancho Santa, US). The FDA issued a Cleared decision on September 7, 2021 after a review of 410 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5150 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Applied Medical Resources Corporation devices

Submission Details

510(k) Number K202049 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 2020
Decision Date September 07, 2021
Days to Decision 410 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
285d slower than avg
Panel avg: 125d · This submission: 410d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code DXE Catheter, Embolectomy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5150
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 - DXE Catheter, Embolectomy

All 73
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