Cleared Traditional

K073620 - GUARDIAN HEMOSTASIS VALVE

K073620 is an FDA 510(k) clearance for GUARDIAN HEMOSTASIS VALVE, manufactured by Zerusa Limited. The device is a Class 2 Cardiovascular device with product code DTL cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K073620 · Zerusa Limited · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2008
Decision
63d
Days
Class 2
Risk

K073620 is an FDA 510(k) clearance for the GUARDIAN HEMOSTASIS VALVE. Classified as Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass (product code DTL), Class II - Special Controls.

Submitted by Zerusa Limited (Galway, IE). The FDA issued a Cleared decision on February 27, 2008 after a review of 63 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 Zerusa Limited devices

FDA 510(k) Submission Details - K073620

510(k) Number K073620 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 2007
Decision Date February 27, 2008
Days to Decision 63 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 125d · This submission: 63d
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 93
Devices cleared under the same product code (DTL) and FDA review panel - the closest regulatory comparables to K073620.
NMI FC
K091634 · Navilyst Medical, Inc. · Mar 2010
GATOR CLIPSEAL PLUG
K092563 · Vascular Solutions, Inc. · Nov 2009
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
Y-CLICK CONNECTOR
K060759 · Elcam Medical Acal · Jun 2006