Cleared Traditional

K223432 - Vassallo GT 018 Hybrid

K223432 is an FDA 510(k) clearance for Vassallo GT 018 Hybrid, manufactured by Filmecc Co., Ltd.. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K223432 · Filmecc Co., Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2023
Decision
115d
Days
Class 2
Risk

K223432 is an FDA 510(k) clearance for the Vassallo GT 018 Hybrid. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Filmecc Co., Ltd. (Nagoya-Shi, JP). The FDA issued a Cleared decision on March 9, 2023 after a review of 115 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1330 - 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 Filmecc Co., Ltd. devices

FDA 510(k) Submission Details - K223432

510(k) Number K223432 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 2022
Decision Date March 09, 2023
Days to Decision 115 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
10d faster than avg
Panel avg: 125d · This submission: 115d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQX Device Classification - Class 2, Special Controls

Product Code DQX Wire, Guide, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1330
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 Peers - DQX Wire, Guide, Catheter

All 541
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