Cleared Traditional

VASOBand Vascular Compression Device (K203803) - FDA 510(k) Clearance

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

K203803 · Vasoinnovations, Inc. · Cardiovascular device
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Jan 2021
Decision
29d
Days
Class 2
Risk

K203803 is an FDA 510(k) clearance for the VASOBand Vascular Compression Device. Classified as Clamp, Vascular (product code DXC), Class II - Special Controls.

Submitted by Vasoinnovations, Inc. (South Pasadena, US). The FDA issued a Cleared decision on January 26, 2021 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4450 - 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 Vasoinnovations, Inc. devices

Submission Details

510(k) Number K203803 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 2020
Decision Date January 26, 2021
Days to Decision 29 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
96d faster than avg
Panel avg: 125d · This submission: 29d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

Product Code DXC Clamp, Vascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4450
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

Regulatory Technology Services, LLC
Prithul Bom

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.

Regulatory Peers - DXC Clamp, Vascular

All 39
Devices cleared under the same product code (DXC) and FDA review panel - the closest regulatory comparables to K203803.
MI DeTACH
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VIOLA
K203307 · Vascular Graft Solutions, Ltd. · Feb 2021
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K191827 · Sunny Medical Device (Shenzhen) Co., Ltd. · Mar 2020