Cleared Traditional

Excipio SV Thrombectomy Device (K221204) - FDA 510(k) Clearance

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

K221204 · Contego Medical, Inc. · Cardiovascular device
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Jun 2022
Decision
58d
Days
Class 2
Risk

K221204 is an FDA 510(k) clearance for the Excipio SV Thrombectomy Device. Classified as Peripheral Mechanical Thrombectomy With Aspiration (product code QEW), Class II - Special Controls.

Submitted by Contego Medical, Inc. (Raleigh, US). The FDA issued a Cleared decision on June 23, 2022 after a review of 58 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 Contego Medical, Inc. devices

Submission Details

510(k) Number K221204 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 2022
Decision Date June 23, 2022
Days to Decision 58 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
67d faster than avg
Panel avg: 125d · This submission: 58d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 119
Devices cleared under the same product code (QEW) and FDA review panel - the closest regulatory comparables to K221204.
INDIGO Aspiration System (CAT RX Aspiration Catheter and Separator 4)
K220683 · Penumbra, Inc. · Oct 2022
Mini-ClotTriever Thrombectomy System
K220887 · Inari Medical · Aug 2022
Protrieve Sheath
K220415 · Inari Medical, Inc. · Jul 2022
Aspirex Thrombectomy System
K220270 · C.R. Bard, Inc. · Jun 2022
Triever24, Triever20
K213402 · Inari Medical · May 2022
Prodigy Thrombectomy System
K214114 · Truvic Medical, Inc. · Apr 2022