Cleared Traditional

CARIOSOLUTIONS PERCU-PRO STEERABLE INTRODCER 65CM CARIOSOLUTIONS PERCU-PRO STEERABLE INTRODUCER 80CM (K120086) - FDA 510(k) Clearance

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

K120086 · Cardiosolutions · Cardiovascular device
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Apr 2012
Decision
104d
Days
Class 2
Risk

K120086 is an FDA 510(k) clearance for the CARIOSOLUTIONS PERCU-PRO STEERABLE INTRODCER 65CM CARIOSOLUTIONS PERCU-PRO ST.... Classified as Catheter, Steerable (product code DRA), Class II - Special Controls.

Submitted by Cardiosolutions (West Bridgewater, US). The FDA issued a Cleared decision on April 24, 2012 after a review of 104 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1280 - 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 Cardiosolutions devices

Submission Details

510(k) Number K120086 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 2012
Decision Date April 24, 2012
Days to Decision 104 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
21d faster than avg
Panel avg: 125d · This submission: 104d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DRA Catheter, Steerable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1280
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 - DRA Catheter, Steerable

All 40
Devices cleared under the same product code (DRA) and FDA review panel - the closest regulatory comparables to K120086.
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