Cleared Traditional

Site Seal SV (K190351) - FDA 510(k) Clearance

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

K190351 · Ensite Vascular · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2019
Decision
138d
Days
Class 2
Risk

K190351 is an FDA 510(k) clearance for the Site Seal SV. Classified as Clamp, Vascular (product code DXC), Class II - Special Controls.

Submitted by Ensite Vascular (Olathe, US). The FDA issued a Cleared decision on July 2, 2019 after a review of 138 days - within the typical 510(k) review window.

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: 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 Ensite Vascular devices

Submission Details

510(k) Number K190351 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 2019
Decision Date July 02, 2019
Days to Decision 138 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
13d slower than avg
Panel avg: 125d · This submission: 138d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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

TAMM Net, Inc.
F. Blix Winston

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 K190351.
Patent Hemostasis Band (PH Band)
K201695 · Medical Ingenuities · Oct 2020
SiteSeal Femoral Compression Device
K192413 · Ensite Vacular, LLC · Mar 2020
Sunmed Disposable Angio-Closure Pads
K191827 · Sunny Medical Device (Shenzhen) Co., Ltd. · Mar 2020
VASOBand Vascular Compression Device
K190318 · Vasoinnovations, Inc. · Mar 2019
PreludeSYNC DISTAL Radial Compression System
K180723 · Merit Medical Systems, Inc. · Apr 2018
ARC ADJUSTABLE RADIAL CUFF COMPRESSION DEVICE
K173563 · Tz Medical, Inc. · Jan 2018