Cleared Traditional

ASAHI PTCA Guide Wire ASAHI Gladius Mongo 14, ASAHI Gladius Mongo 14 ES (K180784) - FDA 510(k) Clearance

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

K180784 · Asahi Intecc Co., Ltd. · Cardiovascular device
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Jul 2018
Decision
114d
Days
Class 2
Risk

K180784 is an FDA 510(k) clearance for the ASAHI PTCA Guide Wire ASAHI Gladius Mongo 14, ASAHI Gladius Mongo 14 ES. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Asahi Intecc Co., Ltd. (Seto, JP). The FDA issued a Cleared decision on July 18, 2018 after a review of 114 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 Asahi Intecc Co., Ltd. devices

Submission Details

510(k) Number K180784 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 2018
Decision Date July 18, 2018
Days to Decision 114 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
11d faster than avg
Panel avg: 125d · This submission: 114d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Consultant

CardioMed Device Consultants, LLC
Candace Cederman

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 - DQX Wire, Guide, Catheter

All 342
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