Cleared Special

K091491 - HERO VASCULAR ACCESS DEVICE

K091491 is an FDA 510(k) clearance for HERO VASCULAR ACCESS DEVICE, manufactured by Hemosphere, Inc.. The device is a Class 2 Cardiovascular device with product code DSY cleared through the Special 510(k) pathway after a 72-day FDA review.

K091491 · Hemosphere, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2009
Decision
72d
Days
Class 2
Risk

K091491 is an FDA 510(k) clearance for the HERO VASCULAR ACCESS DEVICE. Classified as Prosthesis, Vascular Graft, Of 6mm And Greater Diameter (product code DSY), Class II - Special Controls.

Submitted by Hemosphere, Inc. (Eden Prarie, US). The FDA issued a Cleared decision on July 31, 2009 after a review of 72 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3450 - 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 - K091491

510(k) Number K091491 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 2009
Decision Date July 31, 2009
Days to Decision 72 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
53d faster than avg
Panel avg: 125d · This submission: 72d
Pathway characteristics
Modification to existing cleared device.

DSY Device Classification - Class 2, Special Controls

Product Code DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3450
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 - DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter

All 172
Devices cleared under the same product code (DSY) and FDA review panel - the closest regulatory comparables to K091491.
GELWEAVE BRANCHED VASCULAR GRAFTS WITH RADIOPAQUE MARKERS
K093817 · Vascutek, Ltd. · Jan 2010
MAXIFLO, TAPERFLO
K092863 · Vascutek, Ltd. · Oct 2009
VASCUTEK COBRAHOOD EPTFE VASCULAR GRAFTS
K091778 · Vascutek, Ltd. · Aug 2009
VASCUTEK BRANCHED GELWEAVE
K090987 · Vascutek, Ltd. · Jun 2009
EPTFE SLFTM SPIRAL VASCULAR GRAFT
K083169 · Tayside Flow Technologies Limited · Mar 2009
HERO VASCULAR ACCESS DEVICE
K071778 · Graftcath, Inc. · Jan 2008
K091491 · HERO VASCULAR ACCESS DEVICE
Download PDF FDA Summary Hemosphere, Inc.