Cleared Traditional

K192782 - ASAHI CROSSWALK Peripheral Support Cath...

K192782 is the FDA 510(k) clearance for ASAHI CROSSWALK Peripheral Support Cath... by Asahi Intecc Co., Ltd.. It is a Class 2 Cardiovascular device (product code DQY) cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K192782 · Asahi Intecc Co., Ltd. · Cardiovascular device
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Nov 2019
Decision
60d
Days
Class 2
Risk

K192782 is an FDA 510(k) clearance for the ASAHI CROSSWALK Peripheral Support Catheter. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Asahi Intecc Co., Ltd. (Seto, JP). The FDA issued a Cleared decision on November 29, 2019 after a review of 60 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Asahi Intecc Co., Ltd. devices

Submission Details

510(k) Number K192782 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2019
Decision Date November 29, 2019
Days to Decision 60 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
65d faster than avg
Panel avg: 125d · This submission: 60d
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

Asahi Intecc USA, Inc.
Cynthia Valenzuela

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

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