Cleared Traditional

K222185 - Stratus Infusion Catheter (FDA 510(k) Clearance)

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

K222185 · Intervene, Inc. · Cardiovascular device
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Apr 2023
Decision
265d
Days
Class 2
Risk

K222185 is an FDA 510(k) clearance for the Stratus Infusion Catheter. Classified as Catheter, Infusion, Syringe (product code NPG), Class II - Special Controls.

Submitted by Intervene, Inc. (South San Francisco, US). The FDA issued a Cleared decision on April 13, 2023 after a review of 265 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1210 - 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 Intervene, Inc. devices

Submission Details

510(k) Number K222185 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 2022
Decision Date April 13, 2023
Days to Decision 265 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
140d slower than avg
Panel avg: 125d · This submission: 265d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NPG Catheter, Infusion, Syringe
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1210
Definition To Provide Physician Specified Fluids Both Perivascular Or Intraluminal To The Perivascular Space.
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 Consultant

Mark Smutka
Mark Smutka

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.