Cleared Traditional

JETi AIO Peripheral Thrombectomy System (K213565) - FDA 510(k) Clearance

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

K213565 · Walk Vascular, LLC · Cardiovascular device
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Feb 2022
Decision
84d
Days
Class 2
Risk

K213565 is an FDA 510(k) clearance for the JETi AIO Peripheral Thrombectomy System. Classified as Aspiration Thrombectomy Catheter (product code QEZ), Class II - Special Controls.

Submitted by Walk Vascular, LLC (Irvine, US). The FDA issued a Cleared decision on February 1, 2022 after a review of 84 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Walk Vascular, LLC devices

Submission Details

510(k) Number K213565 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 2021
Decision Date February 01, 2022
Days to Decision 84 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
41d faster than avg
Panel avg: 125d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QEZ Aspiration Thrombectomy Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5150
Definition To Remove Thrombus From The Peripheral And/or 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.

Regulatory Peers - QEZ Aspiration Thrombectomy Catheter

All 34
Devices cleared under the same product code (QEZ) and FDA review panel - the closest regulatory comparables to K213565.
AlphaVac MMA F1885 System (H787253020)
K240397 · AngioDynamics, Inc. · Apr 2024
JETi™Hydrodynamic Thrombectomy System
K232458 · Abbott Medical · Dec 2023
AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System
K213388 · AngioDynamics, Inc. · Apr 2022
ASAP Aspiration Catheter, ASAPLP Aspiration Catheter
K212199 · Merit Medical Systems, Inc. · Nov 2021
Thrombuster II Aspiration Catheter
K213166 · Kaneka Medical America, LLC · Oct 2021
AlphaVac Multipurpose Mechanical Aspiration (MMA) System
K211081 · AngioDynamics, Inc. · Jun 2021