Cleared Traditional

K241158 - ASAHI Veloute (FDA 510(k) Clearance)

Also includes:
ASAHI Veloute C3 ASAHI Tellus ASAHI Tellus C3

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

K241158 · Asahi Intecc Co., Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2024
Decision
60d
Days
Class 2
Risk

K241158 is an FDA 510(k) clearance for the ASAHI Veloute. 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 June 25, 2024 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 K241158 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 2024
Decision Date June 25, 2024
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

All 887
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K241158.
Amplatzer TorqVue Delivery System
K260993 · Abbott · Apr 2026
Teleport Glide Microcatheter
K253361 · OrbusNeich Medical (Shenzhen) Co., Ltd. · Apr 2026
Amplatzer™ Trevisio™ Intravascular Delivery System
K260499 · Abbott Medical · Mar 2026
C320LBB Delivery System (C320LBBS45), C320LBB Delivery System (C320LBBS48), C320LBB Delivery System (C320LBBL45), C320LBB Delivery System (C320LBBL48)
K253409 · Medtronic, Inc. · Dec 2025
Amplatzer Piccolo™ Delivery System (9-PDS-04F-045)
K252417 · Abbott Medical · Dec 2025
Telescope Guide Extension Catheter
K252390 · Medtronic, Ireland · Oct 2025