Cleared Traditional

K151103 - ASAHI Corsair Microcatheter

K151103 is an FDA 510(k) clearance for ASAHI Corsair Microcatheter, manufactured by Asahi Intecc Co., Ltd.. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K151103 · Asahi Intecc Co., Ltd. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2015
Decision
60d
Days
Class 2
Risk

K151103 is an FDA 510(k) clearance for the ASAHI Corsair Microcatheter. 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 June 23, 2015 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.

FDA 510(k) Submission Details - K151103

510(k) Number K151103 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 2015
Decision Date June 23, 2015
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.

DQY Device Classification - Class 2, Special Controls

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 861
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K151103.
Wingman Crossing Catheter
K151880 · Reflow Medical · Aug 2015
Metacross RX PTA Balloon Dilitation Catheter
K150865 · KANEKA Corporation · Aug 2015
Arc Intracranial Support Catheter, Arc Mini Intracranial Support Catheter
K150107 · Micro Therapeutics Inc Dba Ev3 Neurovascular · Jul 2015
MicroCross Catheter
K151082 · Roxwood Medical, Inc. · Jun 2015
Coda LP Balloon Catheter
K150970 · Cook Incorporated · May 2015
NovaCross Microcatheter
K143608 · Nitiloop , Ltd. · May 2015
K151103 · ASAHI Corsair Microcatheter
Download PDF FDA Summary Asahi Intecc Co., Ltd.