Cleared Special

K060745 - ASAHI TORNUS SUPPORT CATHETER WITH TORQ...

K060745 is the FDA 510(k) clearance for ASAHI TORNUS SUPPORT CATHETER WITH TORQ... by Asahi Intecc Co., Ltd.. It is a Class 2 Cardiovascular device (product code DQY) cleared through the Special 510(k) pathway after a 95-day FDA review.

K060745 · Asahi Intecc Co., Ltd. · Cardiovascular device
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Jun 2006
Decision
95d
Days
Class 2
Risk

K060745 is an FDA 510(k) clearance for the ASAHI TORNUS SUPPORT CATHETER WITH TORQUE DEVICE ACCESSORY. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Asahi Intecc Co., Ltd. (Newport Beach, US). The FDA issued a Cleared decision on June 23, 2006 after a review of 95 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. 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 K060745 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 2006
Decision Date June 23, 2006
Days to Decision 95 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
30d faster than avg
Panel avg: 125d · This submission: 95d
Pathway characteristics
Modification to existing cleared device.

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

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