Cleared Special

ATTAIN PREVAIL LEFT HEART DELIVERY SYSTEM MODDEL, 6228SYS (K032622) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K032622 · Medtronic Vascular · Cardiovascular device
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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.

View all Medtronic Vascular devices

Submission Details

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.

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 292
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K032622.
COOK CODA BALLOON CATHETER
K032869 · Cook, Inc. · Nov 2003
PTA BALLOON CATHETER
K032931 · Cook, Inc. · Oct 2003
ATTAIN 6226DEF DEFLECTABLE CATHETER DELIVERY SYSTEM
K032312 · Medtronic Vascular · Oct 2003
MEDTRONIOC 7F LAUNCHER BIOPSY GUIDE CATHETER, MODEL LA7RVBB, MEDTRONIC 8F LAUNCHER BIOPSY CATHETER, MODEL LA8RVBB
K030671 · Medtronic Vascular · Jul 2003
ATTAIN PREVAIL STEERABLE CATHETER SET, MODEL 6228CTH
K031211 · Medtronic Vascular · Jul 2003
ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER
K031766 · Cook, Inc. · Jun 2003