Cleared Traditional

K111334 - BENELLI ACCESS DEVICE

K111334 is the FDA 510(k) clearance for BENELLI ACCESS DEVICE by Vascular Solutions, Inc.. It is a Class 2 Cardiovascular device (product code DQY) cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K111334 · Vascular Solutions, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2011
Decision
81d
Days
Class 2
Risk

K111334 is an FDA 510(k) clearance for the BENELLI ACCESS DEVICE. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Vascular Solutions, Inc. (Minneapolis, US). The FDA issued a Cleared decision on August 1, 2011 after a review of 81 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. 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 Vascular Solutions, Inc. devices

Submission Details

510(k) Number K111334 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 2011
Decision Date August 01, 2011
Days to Decision 81 days
Submission Type Traditional
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
44d faster than avg
Panel avg: 125d · This submission: 81d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K111334.
SELECTRA ACCESSORY KIT
K111839 · Biotronik, Inc. · Sep 2011
SELECTRA SLITTER TOOL
K112482 · Biotronik, Inc. · Sep 2011
HEADWAY 27 MICROCATHETER
K110813 · MicroVention, Inc. · Aug 2011
GLIDECROSS SUPPORT CATHETER
K111556 · Terumo Medical Corp. · Jul 2011
NEURON MAX SYSTEM
K111380 · Penumbra, Inc. · Jul 2011
VACCESS PTA DILATATION CATHETER
K111850 · C.R. Bard, Inc. · Jul 2011