Cleared Traditional

K083127 - ASAHI CORSAIR MICROCATHETER

K083127 is the FDA 510(k) clearance for ASAHI CORSAIR MICROCATHETER by Asahi Intecc Co., Ltd.. It is a Class 2 Cardiovascular device (product code DQY) cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K083127 · Asahi Intecc Co., Ltd. · Cardiovascular device
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Feb 2009
Decision
105d
Days
Class 2
Risk

K083127 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. (Santa Ana, US). The FDA issued a Cleared decision on February 3, 2009 after a review of 105 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 K083127 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 2008
Decision Date February 03, 2009
Days to Decision 105 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
20d faster than avg
Panel avg: 125d · This submission: 105d
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 Peers - DQY Catheter, Percutaneous

All 552
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