Cleared Special

K161362 - ASAHI Corsair Armet

K161362 is an FDA 510(k) clearance for ASAHI Corsair Armet, manufactured by Asahi Intecc Co., Ltd.. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Special 510(k) pathway after a 29-day FDA review.

K161362 · 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 2016
Decision
29d
Days
Class 2
Risk

K161362 is an FDA 510(k) clearance for the ASAHI Corsair Armet. 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 14, 2016 after a review of 29 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K161362

510(k) Number K161362 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 2016
Decision Date June 14, 2016
Days to Decision 29 days
Submission Type Special
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
96d faster than avg
Panel avg: 125d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

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 855
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K161362.
Wingman 18 Crossing Catheter
K160848 · Reflow Medical, Inc. · Jul 2016
ARTLINE
K160448 · Health Line International Corporation · Jul 2016
CenterCross Ultra Catheter
K160681 · Roxwood Medical, Inc. · Jun 2016
Guiding Catheter
K153703 · Texasmedical Technologies, Inc. · May 2016
NovaCross Microcatheter
K160389 · Nitiloop , Ltd. · Mar 2016
ASAHI Corsair Armet
K152249 · Asahi Intecc Co., Ltd. · Mar 2016