Cleared Traditional

Vericor Support Catheter (K222679) - FDA 510(k) Clearance

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

K222679 · Vascupatent Medical (Shenzhen) Co., Ltd. · Cardiovascular device
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Nov 2022
Decision
62d
Days
Class 2
Risk

K222679 is an FDA 510(k) clearance for the Vericor Support Catheter. Classified as Catheter, Continuous Flush (product code KRA), Class II - Special Controls.

Submitted by Vascupatent Medical (Shenzhen) Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on November 7, 2022 after a review of 62 days - a notably fast clearance 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: 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 Vascupatent Medical (Shenzhen) Co., Ltd. devices

Submission Details

510(k) Number K222679 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 2022
Decision Date November 07, 2022
Days to Decision 62 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
63d faster than avg
Panel avg: 125d · This submission: 62d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KRA Catheter, Continuous Flush
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1210
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

Mid-Link Consulting Co, Ltd.
Diana Hong

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.

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All 67
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