Cleared Special

K112917 - ATTAIN LDS 6216A LEFT HEART DELIVERY SY...

K112917 is the FDA 510(k) clearance for ATTAIN LDS 6216A LEFT HEART DELIVERY SY... by Medtronic, Inc.. It is a Class 2 Cardiovascular device (product code DQY) cleared through the Special 510(k) pathway after a 24-day FDA review.

K112917 · Medtronic, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2011
Decision
24d
Days
Class 2
Risk

K112917 is an FDA 510(k) clearance for the ATTAIN LDS 6216A LEFT HEART DELIVERY SYSTEM, ATTAIN ACCESS 6218A LEFT HEART D.... Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Medtronic, Inc. (Mounds View, US). The FDA issued a Cleared decision on October 27, 2011 after a review of 24 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. 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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Medtronic, Inc. devices

Submission Details

510(k) Number K112917 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 2011
Decision Date October 27, 2011
Days to Decision 24 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
101d faster than avg
Panel avg: 125d · This submission: 24d
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

All 519
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K112917.
GUIDELINER V2 CATHETER
K112082 · Vascular Solutions, Inc. · Dec 2011
CLEARWAY RX NB CATHETER
K113112 · Atrium Medical Corp. · Nov 2011
RUBICON SUPPORT CATHETER
K112303 · Boston Scientific · Nov 2011
REVIVE INTERMEDIATE CATHETER (REVIVE IC)
K112828 · Codman & Shurtleff, Inc. · Oct 2011
SELECTRA ACCESSORY KIT
K111839 · Biotronik, Inc. · Sep 2011
SELECTRA SLITTER TOOL
K112482 · Biotronik, Inc. · Sep 2011