Cleared Traditional

K152528 - Attachable Cath Lab Hemostasis Valve

K152528 is the FDA 510(k) clearance for Attachable Cath Lab Hemostasis Valve by Galt Medical Corp.. It is a Class 2 Cardiovascular device (product code DTL) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K152528 · Galt Medical Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2015
Decision
90d
Days
Class 2
Risk

K152528 is an FDA 510(k) clearance for the Attachable Cath Lab Hemostasis Valve. Classified as Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass (product code DTL), Class II - Special Controls.

Submitted by Galt Medical Corp. (Garland, US). The FDA issued a Cleared decision on December 2, 2015 after a review of 90 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Galt Medical Corp. devices

Submission Details

510(k) Number K152528 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 2015
Decision Date December 02, 2015
Days to Decision 90 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
35d faster than avg
Panel avg: 125d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 66
Devices cleared under the same product code (DTL) and FDA review panel - the closest regulatory comparables to K152528.
Passage Hemostasis Valve
K143429 · Merit Medical Systems, Inc. · Dec 2014
ROTATING ADAPTERS
K140475 · Merit Medical Systems, Inc. · Apr 2014
AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH BALANCE BIOSURFACE, AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH CARMEDA BIOACTIVE
K123448 · Medtronic, Inc. · Dec 2012
CONNECTOR COMPONENTS WITH BALANCE BIOSURFACE
K122811 · Medtronic, Inc. · Oct 2012
MEDLINE STOPCOCK AND MANIFOLD
K120069 · Medline Industries, Inc. · Apr 2012
TUBING, CONMNECTORS, AND ACCESSORIES WIT BALANCE BIOSURFACE
K113845 · Medtronic, Inc. · Jan 2012