Cleared Traditional

K163031 - Bunegin-Albin Air Aspiration Set (FDA 510(k) Clearance)

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

K163031 · Cook Incorporated · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Jul 2017
Decision
269d
Days
Class 2
Risk

K163031 is an FDA 510(k) clearance for the Bunegin-Albin Air Aspiration Set. Classified as Catheter, Embolectomy (product code DXE), Class II - Special Controls.

Submitted by Cook Incorporated (Bloomington, US). The FDA issued a Cleared decision on July 27, 2017 after a review of 269 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 Cook Incorporated devices

Submission Details

510(k) Number K163031 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 2016
Decision Date July 27, 2017
Days to Decision 269 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
144d slower than avg
Panel avg: 125d · This submission: 269d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DXE Catheter, Embolectomy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5150
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 - DXE Catheter, Embolectomy

All 73
Devices cleared under the same product code (DXE) and FDA review panel - the closest regulatory comparables to K163031.
Fogarty Thru-Lumen Embolectomy Catheter
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Fogarty Venous Thrombectomy Catheters
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Fogarty Arterial Embolectomy Catheter with Gate Valve
K233820 · Edwards Lifesciences · May 2024
Fogarty Corkscrew Catheters
K233619 · Edwards Lifesciences · May 2024
Merlin Aspiration System
K213771 · Mivi Neurovascular, Inc. · Jan 2022