Cleared Traditional

SiteSeal Femoral Compression Device (K192413) - FDA 510(k) Clearance

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

K192413 · Ensite Vacular, LLC · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Mar 2020
Decision
209d
Days
Class 2
Risk

K192413 is an FDA 510(k) clearance for the SiteSeal Femoral Compression Device. Classified as Clamp, Vascular (product code DXC), Class II - Special Controls.

Submitted by Ensite Vacular, LLC (Olathe, US). The FDA issued a Cleared decision on March 31, 2020 after a review of 209 days - an extended review 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: 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 Vacular, LLC devices

Submission Details

510(k) Number K192413 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 2019
Decision Date March 31, 2020
Days to Decision 209 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
84d slower than avg
Panel avg: 125d · This submission: 209d
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.
Shree Koushik

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 203
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