Cleared Traditional

ASAHI Caravel (K152447) - FDA 510(k) Clearance

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

K152447 · Asahi Intecc Co., Ltd. · Cardiovascular device
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Jan 2016
Decision
148d
Days
Class 2
Risk

K152447 is an FDA 510(k) clearance for the ASAHI Caravel. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Asahi Intecc Co., Ltd. (Hagoya-Shi, JP). The FDA issued a Cleared decision on January 22, 2016 after a review of 148 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - 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 K152447 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 2015
Decision Date January 22, 2016
Days to Decision 148 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
23d slower than avg
Panel avg: 125d · This submission: 148d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQY Catheter, Percutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
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 - DQY Catheter, Percutaneous

All 449
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