INDIGO Aspiration System

FDA 510(k) K163618 · Penumbra, Inc.

Unknown

510(k) numberK163618

Submission

Device name
INDIGO Aspiration System
Applicant
Penumbra, Inc.
Alameda, CA, US
Received
December 22, 2016
Decision date
May 24, 2017
Decision
Unknown (SESU)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
QEX – Coronary Mechanical Thrombectomy With Aspiration
Device class
Class II (moderate risk)
Regulation
21 CFR 870.5150
Specialty
Cardiovascular

To mechanically disrupt thrombus and/or debris prior to removal from the coronary vasculature through aspiration.

Other 510(k)s with product code QEX

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K253407NeVa PV Thrombectomy DeviceQEX · Traditional Vesalio, Inc.11/24/2025SESU
K171493MegaVac Mechanical Thrombectomy SystemQEX · Special Capture Vascular, Inc.08/10/2017SE

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K252612INDIGO® Aspiration System – Lightning Flash Aspiration Tubing; INDIGO® Aspiration System…QEW · Traditional 10/16/2025SE
K250079Ruby XL SystemKRD · Traditional 03/14/2025SE
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K242033Access25™ Delivery MicrocatheterQJP · Traditional 12/11/2024SE
K242520Element Vascular Access SystemDYB · Traditional 11/20/2024SE
K242075Indigo® Aspiration System – Lightning Bolt Aspiration TubingQEW · Traditional 09/25/2024SE
K242319Indigo® Aspiration System – Aspiration Catheter 6XQEW · Special 09/03/2024SE

Questions and answers

When was INDIGO Aspiration System cleared by the FDA?

INDIGO Aspiration System (K163618) received a 510(k) decision of Unknown on May 24, 2017, 153 days after the submission was received.

What is the product code of K163618?

The FDA product code is QEX – Coronary Mechanical Thrombectomy With Aspiration, a Class II (moderate risk) device regulated under 21 CFR 870.5150.