Cleared Traditional

K034010 - GELSOFT PLUS ERS

K034010 is an FDA 510(k) clearance for GELSOFT PLUS ERS, manufactured by Vascutek, Ltd.. The device is a Class 2 Cardiovascular device with product code DSY cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K034010 · Vascutek, Ltd. · Cardiovascular device
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Feb 2004
Decision
57d
Days
Class 2
Risk

K034010 is an FDA 510(k) clearance for the GELSOFT PLUS ERS. Classified as Prosthesis, Vascular Graft, Of 6mm And Greater Diameter (product code DSY), Class II - Special Controls.

Submitted by Vascutek, Ltd. (Ann Arbor, US). The FDA issued a Cleared decision on February 19, 2004 after a review of 57 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Vascutek, Ltd. devices

FDA 510(k) Submission Details - K034010

510(k) Number K034010 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 24, 2003
Decision Date February 19, 2004
Days to Decision 57 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 125d · This submission: 57d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 125
Devices cleared under the same product code (DSY) and FDA review panel - the closest regulatory comparables to K034010.
VASCUTEK PTFE SUPPORTED EPTFE VASCULAR PROSTHESES
K043552 · Vascutek, Ltd. · Jan 2005
MODIFICATION TO EPTFE GRAFT
K041528 · Vascutek, Ltd. · Sep 2004
GELWEAVE ANTE-FLO WITH COLLAR AND GELWEAVE 4 BRANCH PLEXUS WITH COLLAR
K040829 · Vascutek, Ltd. · May 2004
LIFESPAN REINFORCED EPTFE STRAIGHT VASCULAR GRAFTS, EXTERNALLY SUPPORTED VASCULAR GRAFTS, STEPPED VASCULAR GRAFTS
K032900 · Edwards Lifesciences, LLC · Dec 2003
EPTFE VASCULAR PROSTHESIS
K030999 · Vascutek, Ltd. · Apr 2003
ADVANTA SST BIFURCATED GRAFT
K020767 · Atrium Medical Corp. · Apr 2002