Cleared Traditional

K260677 - Vessel Closure Device (VCD177213P)

K260677 is an FDA 510(k) clearance for Vessel Closure Device (VCD177213P), manufactured by Vcd Medical S.R.L.. The device is a Class 2 Cardiovascular device with product code FZP cleared through the Traditional 510(k) pathway after a 199-day FDA review.

K260677 · Vcd Medical S.R.L. · Cardiovascular device
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Sep 2026
Decision
199d
Days
Class 2
Risk

K260677 is an FDA 510(k) clearance for the Vessel Closure Device (VCD177213P). Classified as Clip, Implantable (product code FZP), Class II - Special Controls.

Submitted by Vcd Medical S.R.L. (Brescia, IT). The FDA issued a Cleared decision on September 17, 2026 after a review of 199 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 878.4300 - 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 Vcd Medical S.R.L. devices

FDA 510(k) Submission Details - K260677

510(k) Number K260677 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 2026
Decision Date September 17, 2026
Days to Decision 199 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
74d slower than avg
Panel avg: 125d · This submission: 199d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FZP Device Classification - Class 2, Special Controls

Product Code FZP Clip, Implantable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4300
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

RQM+
David Worrell

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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