Cleared Traditional

K092563 - GATOR CLIPSEAL PLUG

K092563 is an FDA 510(k) clearance for GATOR CLIPSEAL PLUG, manufactured by Vascular Solutions, Inc.. The device is a Class 2 Cardiovascular device with product code DTL cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K092563 · Vascular Solutions, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2009
Decision
76d
Days
Class 2
Risk

K092563 is an FDA 510(k) clearance for the GATOR CLIPSEAL PLUG. Classified as Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass (product code DTL), Class II - Special Controls.

Submitted by Vascular Solutions, Inc. (Minneapolis, US). The FDA issued a Cleared decision on November 4, 2009 after a review of 76 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4290 - 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

FDA 510(k) Submission Details - K092563

510(k) Number K092563 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 2009
Decision Date November 04, 2009
Days to Decision 76 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
49d faster than avg
Panel avg: 125d · This submission: 76d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DTL Device Classification - Class 2, Special Controls

Product Code DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4290
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 - DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

All 100
Devices cleared under the same product code (DTL) and FDA review panel - the closest regulatory comparables to K092563.
TERUMO LAUER LOCK ADAPTER
K093992 · Terumo Cardiovascular Systems Corporation · May 2010
MERIT MANIFOLD WITH INTEGRATED TRANSDUCER, MODEL 203LTCHN-R
K100319 · Merit Medical Systems, Inc. · Apr 2010
NMI FC
K091634 · Navilyst Medical, Inc. · Mar 2010
CAPIOX CIRCUIT CONNECTORS
K073474 · Terumo Corp. · Mar 2008
Y-GLIDE
K072745 · Thomas Medical Products, Inc. · Jan 2008
HEMOSTASIS VALVE
K072556 · Merit Medical Systems, Inc. · Nov 2007