Cleared Traditional

K072313 - AMPLATZER TORQVUE DELIVERY SYSTEM

K072313 is an FDA 510(k) clearance for AMPLATZER TORQVUE DELIVERY SYSTEM, manufactured by Aga Medical Corp.. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K072313 · Aga Medical Corp. · Cardiovascular device
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Nov 2007
Decision
77d
Days
Class 2
Risk

K072313 is an FDA 510(k) clearance for the AMPLATZER TORQVUE DELIVERY SYSTEM. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Aga Medical Corp. (Plymouth, US). The FDA issued a Cleared decision on November 2, 2007 after a review of 77 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Aga Medical Corp. devices

FDA 510(k) Submission Details - K072313

510(k) Number K072313 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 2007
Decision Date November 02, 2007
Days to Decision 77 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 125d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Peers - DQY Catheter, Percutaneous

All 659
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K072313.
ADVANCE 18LP PTA DILATATION CATHETER
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SPECTRANETICS QUICK-CROSS SUPPORT2 CATHETERS, MODELS 518-065 AND 518-066
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TWIN-PASS OTW CATHETER, MODEL 5201
K072618 · Vascular Solutions, Inc. · Nov 2007
DORADO PTA BALLOON DILATATION CATHETER
K072283 · Bard Peripheral Vascular, Inc. · Sep 2007
PRECIOUS PLUS GUIDE CATHETER
K072316 · Asahi Intecc Co., Ltd. · Sep 2007
NEURON SUPPORT CATHETER SYSTEM, MODEL 5F/6F
K070970 · Penumbra, Inc. · Aug 2007