Cleared Traditional

K160533 - Penumbra Embolectomy Aspiration System ...

K160533 is an FDA 510(k) clearance for Penumbra Embolectomy Aspiration System ..., 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 96-day FDA review.

K160533 · Penumbra, Inc. · Cardiovascular device
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May 2016
Decision
96d
Days
Class 2
Risk

K160533 is an FDA 510(k) clearance for the Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System). 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 May 24, 2016 after a review of 96 days - within the typical 510(k) review window.

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 - K160533

510(k) Number K160533 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 2016
Decision Date May 24, 2016
Days to Decision 96 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
29d faster than avg
Panel avg: 125d · This submission: 96d
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 131
Devices cleared under the same product code (QEW) and FDA review panel - the closest regulatory comparables to K160533.
FlowTriever Retrieval/Aspiration System, Aspiration Guide Catheter, Retraction Aspirator
K162970 · Inari Medical · Nov 2016
Penumbra Aspiration System
K161506 · Penumbra, Inc. · Sep 2016
INDIGO Aspiration System
K161523 · Penumbra, Inc. · Jul 2016
ZelanteDVT Thrombectomy Set
K151313 · Boston Scientific Corporation · Sep 2015
Retraction Aspirator
K152097 · Inari Medical · Aug 2015
Penumbra Embolectomy Aspiration System [INDIGO Aspiration System]
K142870 · Penumbra, Inc. · May 2015