Cleared Traditional

K201057 - Bio-Medicus Life Support Catheter and Introducer (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K201057 · Medtronic, Inc. · Cardiovascular device
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Jan 2022
Decision
633d
Days
Class 2
Risk

K201057 is an FDA 510(k) clearance for the Bio-Medicus Life Support Catheter and Introducer. Classified as Single Lumen Ecmo Cannula (product code QHW), Class II - Special Controls.

Submitted by Medtronic, Inc. (Mounds View, US). The FDA issued a Cleared decision on January 14, 2022 after a review of 633 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4100 - 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: 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 Medtronic, Inc. devices

Submission Details

510(k) Number K201057 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 2020
Decision Date January 14, 2022
Days to Decision 633 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
508d slower than avg
Panel avg: 125d · This submission: 633d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QHW Single Lumen Ecmo Cannula
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4100
Definition Single-lumen Cannulas/catheters To Be Used With An Extracorporeal Circuit Intended For Use In Patients With Acute Respiratory Failure Or Acute Cardiopulmonary Failure, Where Other Available Treatment Options Have Failed, And Continued Clinical Deterioration Is Expected Or The Risk Of Death Is Imminent.
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.