Cleared Special

K101985 - ASAHI GUIDE WIRE EXTENSION 165CM

K101985 is the FDA 510(k) clearance for ASAHI GUIDE WIRE EXTENSION 165CM by Asahi Intecc Co., Ltd.. It is a Class 2 Cardiovascular device (product code DQX) cleared through the Special 510(k) pathway after a 236-day FDA review.

K101985 · Asahi Intecc Co., Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2011
Decision
236d
Days
Class 2
Risk

K101985 is an FDA 510(k) clearance for the ASAHI GUIDE WIRE EXTENSION 165CM. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Asahi Intecc Co., Ltd. (Santa Ana, US). The FDA issued a Cleared decision on March 7, 2011 after a review of 236 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1330 - 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Asahi Intecc Co., Ltd. devices

Submission Details

510(k) Number K101985 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 2010
Decision Date March 07, 2011
Days to Decision 236 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
111d slower than avg
Panel avg: 125d · This submission: 236d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code DQX Wire, Guide, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1330
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 - DQX Wire, Guide, Catheter

All 452
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