FDA 510(k) Applications Submitted by John Carline
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K011901 |
06/18/2001 |
FIRSTSAVE STAR BIPHASIC, MODEL 9210/9200 |
SURVIVALINK CORP. |
| K022210 |
07/08/2002 |
MULTIFUNCTIONAL ELECTRODE MODELS 9640, 9650 |
CARDIAC SCIENCE, INC. |
| K042117 |
08/05/2004 |
PROXIS SYSTEM, MODEL EPS 101 |
VELOCIMED INC. |
| K022929 |
09/04/2002 |
PEDIATRIC ATTENUATED DEFIBRILLATION ELECTRODES, MODEL 9730, POWEDERHEART AED, MODEL 9200/9210 |
CARDIAC SCIENCE, INC. |
| K072748 |
09/27/2007 |
MODIFICATION TO: DIAMONDBACK 360 ORBITAL ATHERECTOMY SYSTEM |
CARDIOVASCULAR SYSTEMS, INC. |
| K233357 |
09/29/2023 |
EsoCool Thermal Regulation Catheter |
Nuvaira, Inc. |
| K072800 |
10/01/2007 |
DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM |
CARDIOVASCULAR SYSTEMS, INC. |
| K042910 |
10/21/2004 |
VENTURE WIRE CONTROL CATHETER, MODEL WCC |
VELOCIMED INC. |
| K023548 |
10/22/2002 |
PROXIS FLOW-CONTROL DEVICE, MODELS EPS 101, IC 101 |
VELOCIMED |
| K043084 |
11/08/2004 |
PREMERE DELIVERY SHEATH, MODEL PDS |
VELOCIMED INC. |
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