Medical Device Manufacturer · US , Phoenix , AZ

Elcam Medical Acal

16 submissions · 16 cleared · Since 2003
16
Total
16
Cleared
0
Denied

Elcam Medical Acal — FDA 510(k) Submissions

Elcam Medical Acal has submitted 16 FDA 510(k) premarket notifications since 2003, of which 16 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Stopcock, I.v. Set, Transducer, Blood-pressure, Extravascular, Syringe, Piston, Catheter, Intravascular, Diagnostic, Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass . Use the specialty filter in the sidebar to narrow results.

16 devices
1–16 of 16
A-TAP (previously called Arthrotap)
K231900 · FMF Syringe, Piston · General Hospital
Jul 2023 27d
SafePort(TM) Manifold (or Stopcock)
K211204 · FMG Stopcock, I.v. Set · General Hospital
Sep 2022 511d
Elcam Stopcocks and Manifolds
K190489 · FMG Stopcock, I.v. Set · General Hospital
Apr 2019 54d
ELCAM STOPCOCKS AND MANIFOLDS
K141254 · FMG Stopcock, I.v. Set · General Hospital
Jul 2014 77d
DISPOSABLE HIGH PRESSURE STOPCOCK/MANIFOLD MODEL HP STOPCOCK, MP STOPCOCK, HP MANIFOLD, PHP MANIFOLD
K123084 · FMG Stopcock, I.v. Set · General Hospital
May 2013 234d
ELCAM VITAL SIGNS WIRELESS SYSTEM (VSWS)
K120253 · DRG Transmitters And... · Cardiovascular
Jul 2012 171d
ELCAM DISPOSABLE INTEGRATED PRESSURE TRANSDUCER (DIPT)
K120624 · DRS Transducer,... · Cardiovascular
Jun 2012 99d
FLEXI-Q DV AND DVR AUTO-INJECTORS
K111467 · KZH Introducer, Syringe Needle · General Hospital
Feb 2012 259d
SAFEPORT MANIFOLD (TM) (OR STOPCOCK)
K111016 · FPA Set, Administration,... · General Hospital
Jun 2011 58d
HASKAL TORQUE DEVICE
K100425 · DQX Wire, Guide, Catheter · Cardiovascular
Jun 2010 121d
ELCAM ANTIMICROBIAL CLOSED STOPCOCKS (DSS AND TSS)
K082106 · FMG Stopcock, I.v. Set · General Hospital
Oct 2008 69d
Y-CLICK CONNECTOR
K060759 · DTL Adaptor, Stopcock,... · Cardiovascular
Jun 2006 100d
BACSTOP
K053405 · FMG Stopcock, I.v. Set · General Hospital
May 2006 155d
CLOSED SWABABLE STOPCOCK AND MINIMAL RESIDUAL VOLUME LUER-ACTIVATED SWABABLE-STOPCOCK
K060231 · FMG Stopcock, I.v. Set · General Hospital
Apr 2006 73d
H-FLOW VALVE
K034043 · DQO Catheter, Intravascular,... · Cardiovascular
Jun 2004 184d
INDUCTION AND SAMPLING MANIFOLD (OR STOPCOCK)
K032393 · FMG Stopcock, I.v. Set · General Hospital
Sep 2003 39d
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