Cleared Traditional

K061480 - ATTAIN 6227DEF DEFLECTABLE CATHETER DEL...

K061480 is an FDA 510(k) clearance for ATTAIN 6227DEF DEFLECTABLE CATHETER DEL..., manufactured by Medtronic, Ireland. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K061480 · Medtronic, Ireland · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2006
Decision
83d
Days
Class 2
Risk

K061480 is an FDA 510(k) clearance for the ATTAIN 6227DEF DEFLECTABLE CATHETER DELIVERY SYSTEM. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Medtronic, Ireland (Shoreview, US). The FDA issued a Cleared decision on August 21, 2006 after a review of 83 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 Medtronic, Ireland devices

FDA 510(k) Submission Details - K061480

510(k) Number K061480 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 2006
Decision Date August 21, 2006
Days to Decision 83 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
42d faster than avg
Panel avg: 125d · This submission: 83d
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 620
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