Cleared Traditional

K034043 - H-FLOW VALVE

K034043 is an FDA 510(k) clearance for H-FLOW VALVE, manufactured by Elcam Medical Acal. The device is a Class 2 Cardiovascular device with product code DQO cleared through the Traditional 510(k) pathway after a 184-day FDA review.

K034043 · Elcam Medical Acal · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2004
Decision
184d
Days
Class 2
Risk

K034043 is an FDA 510(k) clearance for the H-FLOW VALVE. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Elcam Medical Acal (Mp. Merom Hagalil, IL). The FDA issued a Cleared decision on June 30, 2004 after a review of 184 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1200 - 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 Elcam Medical Acal devices

FDA 510(k) Submission Details - K034043

510(k) Number K034043 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 2003
Decision Date June 30, 2004
Days to Decision 184 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
59d slower than avg
Panel avg: 125d · This submission: 184d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQO Device Classification - Class 2, Special Controls

Product Code DQO Catheter, Intravascular, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1200
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 - DQO Catheter, Intravascular, Diagnostic

All 321
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K034043.
LANGSTON DUAL LUMEN PRESSURE MONITORING CATHETER
K050168 · Vascular Solutions, Inc. · May 2005
ATLANTIS SR PRO2 CORONARY IMAGING CATHETER, MODEL 39014
K050577 · Boston Scientific Corp · Mar 2005
VASCULAR SOLUTIONS LANGSTON DUAL LUMEN PIGTAIL CATHETER (DLP)
K041909 · Vascular Solutions, Inc. · Sep 2004
PTA, PTV, ATRIOSEPTOSTOMY, ANGIOGRAPHIC, SIZING CATHETERS
K040830 · NuMED, Inc. · Jun 2004
ATLANTIS SR, MODEL C4020
K040776 · Boston Scientific Corp · Apr 2004
PROGREAT
K033583 · Terumo Medical Corp. · Dec 2003