Cleared Special

ASAHI PTCA GUIDE WIRE ASAHI SION BLUE 180CM ASAHI PTCA GUIDE WIRE ASAHI SION BLUE 3300CM ASAHI PTCA GUIDE WIRE ASAHI SIO (K122468) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K122468 · Asahi Intecc Co., Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2013
Decision
207d
Days
Class 2
Risk

K122468 is an FDA 510(k) clearance for the ASAHI PTCA GUIDE WIRE ASAHI SION BLUE 180CM ASAHI PTCA GUIDE WIRE ASAHI SION .... 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 8, 2013 after a review of 207 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 K122468 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 2012
Decision Date March 08, 2013
Days to Decision 207 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
82d slower than avg
Panel avg: 125d · This submission: 207d
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 763
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