Cleared Special

K032622 - ATTAIN PREVAIL LEFT HEART DELIVERY SYSTEM MODDEL, 6228SYS

K032622 is an FDA 510(k) clearance for ATTAIN PREVAIL LEFT HEART DELIVERY SYST..., manufactured by Medtronic Vascular. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Special 510(k) pathway after a 8-day FDA review.

K032622 · Medtronic Vascular · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2003
Decision
8d
Days
Class 2
Risk

K032622 is an FDA 510(k) clearance for the ATTAIN PREVAIL LEFT HEART DELIVERY SYSTEM MODDEL, 6228SYS. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Medtronic Vascular (Fridley, US). The FDA issued a Cleared decision on September 3, 2003 after a review of 8 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.

FDA 510(k) Submission Details - K032622

510(k) Number K032622 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 2003
Decision Date September 03, 2003
Days to Decision 8 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
117d faster than avg
Panel avg: 125d · This submission: 8d
Pathway characteristics
Modification to existing cleared device.

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 895
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K032622.
CORDIS POWERFLEX EXTREME PTA BALLOON CATHETER, CORDIS POWERFLEX PLUS PTA BALLOON CATHETER, CORDIS POWERFLEX P3 PTA
K032737 · Cordis Europa, N.V. · Oct 2003
NUMED TYSHAK MINI PEDIATRIC PTV CATHETER
K032591 · NuMED, Inc. · Sep 2003
EDWARDS DIRECTIONAL CATHETER
K030630 · Edwards Lifesciences, LLC · Sep 2003
WORKHORSE II PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER
K032069 · AngioDynamics, Inc. · Aug 2003
MODIFICATION TO OUTBACK CATHETER
K032298 · Lumend, Inc. · Aug 2003
SAFE-CROSS DEFLECTING CATHETER, MODEL C114ND1
K031692 · Intra Luminal Therapeutics, Inc. · Aug 2003
K032622 · ATTAIN PREVAIL LEFT HEART DELIVERY SYSTEM MODDEL, 6228SYS
Download PDF FDA Summary Medtronic Vascular