Cleared Traditional

K152528 - Attachable Cath Lab Hemostasis Valve

K152528 is an FDA 510(k) clearance for Attachable Cath Lab Hemostasis Valve, manufactured by Galt Medical Corp.. The device is a Class 2 Cardiovascular device with 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

FDA 510(k) Submission Details - K152528

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
Combination Product No
PCCP Authorized No
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.

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 102
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
COLIGN
K131124 · Jilin Coronado Medical , Ltd. · Aug 2013
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
GUARDIAN II HEMOSTASIS VALVE GUARDIAN II NC HEMOSTASIS VALVE
K122301 · Vascular Solutions Zerusa , Ltd. · Sep 2012