Cleared Traditional

K163618 - INDIGO Aspiration System

K163618 is an FDA 510(k) clearance for INDIGO Aspiration System, manufactured by Penumbra, Inc.. The device is a Class 2 Cardiovascular device with product code QEX cleared through the Traditional 510(k) pathway after a 153-day FDA review.

K163618 · Penumbra, Inc. · Cardiovascular device
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May 2017
Decision
153d
Days
Class 2
Risk

K163618 is an FDA 510(k) clearance for the INDIGO Aspiration System. Classified as Coronary Mechanical Thrombectomy With Aspiration (product code QEX), Class II - Special Controls.

Submitted by Penumbra, Inc. (Alameda, US). The FDA issued a Cleared decision on May 24, 2017 after a review of 153 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5150 - 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 Penumbra, Inc. devices

FDA 510(k) Submission Details - K163618

510(k) Number K163618 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received December 22, 2016
Decision Date May 24, 2017
Days to Decision 153 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
28d slower than avg
Panel avg: 125d · This submission: 153d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

QEX Device Classification - Class 2, Special Controls

Product Code QEX Coronary Mechanical Thrombectomy With Aspiration
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5150
Definition To Mechanically Disrupt Thrombus And/or Debris Prior To Removal From The Coronary Vasculature Through Aspiration.
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.