Cleared Traditional

K152090 - Reprocessed Steerable Introducer (FDA 510(k) Clearance)

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

K152090 · Sterilmed, Inc. · Cardiovascular device
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Mar 2016
Decision
240d
Days
Class 2
Risk

K152090 is an FDA 510(k) clearance for the Reprocessed Steerable Introducer. Classified as Reprocessed Catheter Introducer (product code PNE), Class II - Special Controls.

Submitted by Sterilmed, Inc. (Plymouth, US). The FDA issued a Cleared decision on March 23, 2016 after a review of 240 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1340 - 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 Sterilmed, Inc. devices

Submission Details

510(k) Number K152090 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 2015
Decision Date March 23, 2016
Days to Decision 240 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
115d slower than avg
Panel avg: 125d · This submission: 240d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PNE Reprocessed Catheter Introducer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1340
Definition Introduce Various Cardiovascular Catheters Into The Heart And Cardiovascular System
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 - PNE Reprocessed Catheter Introducer

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