Cleared Traditional

K193595 - Indigo Aspiration System - Aspiration Catheter 7 and Separator 7

K193595 is an FDA 510(k) clearance for Indigo Aspiration System - Aspiration C..., manufactured by Penumbra, Inc.. The device is a Class 2 Cardiovascular device with product code QEW cleared through the Traditional 510(k) pathway after a 240-day FDA review.

K193595 · Penumbra, Inc. · Cardiovascular device
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Aug 2020
Decision
240d
Days
Class 2
Risk

K193595 is an FDA 510(k) clearance for the Indigo Aspiration System - Aspiration Catheter 7 and Separator 7. Classified as Peripheral Mechanical Thrombectomy With Aspiration (product code QEW), Class II - Special Controls.

Submitted by Penumbra, Inc. (Alameda, US). The FDA issued a Cleared decision on August 19, 2020 after a review of 240 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 - K193595

510(k) Number K193595 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2019
Decision Date August 19, 2020
Days to Decision 240 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
115d slower than avg
Panel avg: 125d · This submission: 240d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

QEW Device Classification - Class 2, Special Controls

Product Code QEW Peripheral 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 Peripheral 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.

Regulatory Peers - QEW Peripheral Mechanical Thrombectomy With Aspiration

All 136
Devices cleared under the same product code (QEW) and FDA review panel - the closest regulatory comparables to K193595.
ZelanteDVT THrombectomy System, ZelanteDVT ClotHunter Helical Rotation Device
K202218 · Boston Scientific Corporation · Oct 2020
Pounce Thrombus Retrieval System
K192814 · Surmodics,Inc. · Sep 2020
ClotTriever Thrombectomy System
K193462 · Inari Medical · Sep 2020
CAPERE Thrombectomy System
K201216 · Vascular Medcure, Inc. · Jul 2020
Indigo System Aspiration Catheter 12, Indigo Aspiration System Separator 12
K192981 · Penumbra, Inc. · May 2020
WOLF Thrombectomy V System
K200101 · Devoro Medical, Inc. · Apr 2020