Cleared Traditional

3T L. V. CONTROL VALVE (K001245) - FDA 510(k) Clearance

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

K001245 · 3t Medical Systems, LLC · Cardiovascular device
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Aug 2001
Decision
484d
Days
Class 2
Risk

K001245 is an FDA 510(k) clearance for the 3T L. V. CONTROL VALVE. Classified as Cpb Check Valve, Retrograde Flow, In-line (product code MJJ), Class II - Special Controls.

Submitted by 3t Medical Systems, LLC (Troy, US). The FDA issued a Cleared decision on August 15, 2001 after a review of 484 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4400 - 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 3t Medical Systems, LLC devices

Submission Details

510(k) Number K001245 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 2000
Decision Date August 15, 2001
Days to Decision 484 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
359d slower than avg
Panel avg: 125d · This submission: 484d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MJJ Cpb Check Valve, Retrograde Flow, In-line
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4400
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.