Cleared Traditional

K080994 - AMPLATZER TORQVUE EXCHANGE SYSTEM

K080994 is an FDA 510(k) clearance for AMPLATZER TORQVUE EXCHANGE 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 39-day FDA review.

K080994 · Aga Medical Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2008
Decision
39d
Days
Class 2
Risk

K080994 is an FDA 510(k) clearance for the AMPLATZER TORQVUE EXCHANGE 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 May 16, 2008 after a review of 39 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 - K080994

510(k) Number K080994 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 2008
Decision Date May 16, 2008
Days to Decision 39 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
86d faster than avg
Panel avg: 125d · This submission: 39d
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
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