Cleared Traditional

K123153 - ATTAIN COMMAND+SUREVALVE LEFT HEART DEL...

K123153 is an FDA 510(k) clearance for ATTAIN COMMAND+SUREVALVE LEFT HEART 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 182-day FDA review.

K123153 · Medtronic, Ireland · Cardiovascular device
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Apr 2013
Decision
182d
Days
Class 2
Risk

K123153 is an FDA 510(k) clearance for the ATTAIN COMMAND+SUREVALVE LEFT HEART DELIVERY SYSTEM ATTAIN COMMAND GUIDE CATH.... Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Medtronic, Ireland (Galway, IE). The FDA issued a Cleared decision on April 9, 2013 after a review of 182 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Medtronic, Ireland devices

FDA 510(k) Submission Details - K123153

510(k) Number K123153 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 09, 2012
Decision Date April 09, 2013
Days to Decision 182 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
57d slower than avg
Panel avg: 125d · This submission: 182d
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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