FDA 510(k) Applications Submitted by LISA J STONE
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K970269 |
01/23/1997 |
CLINICATH IR PERIPHERALLY INSERTED CATHETER |
SIMS DELTEC, INC. |
| K020655 |
03/01/2002 |
DELTEC INSULIN INFUSION PUMP AND ACCESSORIES |
DELTEC, INC. |
| K000842 |
03/15/2000 |
CADD-PRIZM PCS II MODEL 6101 AMBULATORY INFUSION SYSTEM |
SIMS DELTEC, INC. |
| K000942 |
03/23/2000 |
CADD CHECKVALVE ADMINISTRATION SET, MODEL 21-7090 |
SIMS DELTEC, INC. |
| K030983 |
03/28/2003 |
TRUFLOW DUAL-LUMEN POLYURETHANE LONG-TERM STRAIGHT DIALYSIS CATHETER (12.5 FR X 24 CM) WITH TRAY, TRUFLOW DUAL-LUMEN POY |
DELTEC, INC. |
| K961580 |
04/24/1996 |
PORT-A-CATH P.A.S. PORT II IMPLANTABLE VENOUS ACCESS SYTEMS |
SIMS DELTEC, INC. |
| K091206 |
04/24/2009 |
SLEUTH AT IMPLANTABLE CARDIAC MONITORING SYSTEM-6 AND 8CM ANTENNA, PERSONAL DIAGNOSTIC MANAGER(PDM) ACCESSORY KIT, MODEL |
TRANSOMA MEDICAL |
| K031361 |
04/30/2003 |
CADD HIGH-VOLUME ADMINISTRATION SETS WITH FLOWSTOP |
DELTEC, INC. |
| K111657 |
06/14/2011 |
AFFINITY CP CENTRIFUGAL BLOOD PUMP WITH BALANCE BIOSURFACE |
MEDTRONIC, INC. |
| K111658 |
06/14/2011 |
AFFINITY CP CENTRIFUGAL BLLOD PUMP WITH CARMEDA BIOACTIVE SURFACE |
MEDTRONIC INC. |
| K021999 |
06/19/2002 |
GRIPPER PLUS NEEDLE |
DELTEC, INC. |
| K131964 |
06/27/2013 |
BIO-CONSOLE 560 EXTRACORPOREAL BLOOD PUMPING CONSOLE |
MEDTRONIC INC. |
| K022221 |
07/09/2002 |
TRUFLOW LONG-TERM AND SHORT-TERM DUAL-LUMEN DIALYSIS CATHETERS |
DELTEC, INC. |
| K132712 |
08/29/2013 |
AFFINITY CP CENTRIFUGAL BLOOD PUMP WITH OR WITHOUT COATING, AFFINITY CP ADAPTER |
MEDTRONIC INC. |
| K172626 |
09/01/2017 |
Affinity Fusion Oxygenator with Balance Biosurface, Affinity Fusion Oxygenator with Cardiotomy/Venous Reservoir and Balance Biosurface, Affinity Fusion Oxygenator with Cortiva Biosurface, Affinity Fusion Oxygenator with Cortiva BioActive Surface & Cardiot |
Medtronic, Inc. |
| K142784 |
09/26/2014 |
Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda BioActive Surface |
Medtronic, Inc |
| K172984 |
09/27/2017 |
Affinity Pixie Oxygenator with Balance Biosurface, Affinity Pixie Oxygenator with Cardiotomy/Venous Reservoir and Balance Biosurface, Affinity Pixie Oxygenator with Cortiva BioActive Surface, Affinity Fusion Oxygenator with Cardiotomy/Venous Reservoir and |
Medtronic, Inc. |
| K973862 |
10/09/1997 |
PORT-A-CATH LOW-PROFILE IMPLANTABLE ACCESS SYSTEMS |
SIMS DELTEC, INC. |
| K073147 |
11/08/2007 |
SLEUTH IMPLANTABLE ECG SYSTEM-8 CM ACCESSORY KIT, MODEL 3000-08 |
TRANSOMA MEDICAL |
| K984055 |
11/13/1998 |
CLINICATH POLYFLOW POLYURETHANE PERIPHERALLY INSERTED CATHETERS |
SIMS DELTEC, INC. |
| K974471 |
11/26/1997 |
PORT-A-CATH- II DUAL-LUMEN LOW PROFILE SYSTEM, PORT-A-CATH II DUAL LUMEN LOW PROFILE SYSTEM WITH INTRODUCER SET, PORT-A |
SIMS DELTEC, INC. |
| K955407 |
11/27/1995 |
PORT-A-CATH DUAL LUMEN IMPLANTABLE VENOUS |
SIMS DELTEC, INC. |
| K974661 |
12/15/1997 |
0.2 U BACTERIAL FILTER |
SIMS DELTEC, INC. |
| K994216 |
12/15/1999 |
PLASTIC PORT IMPLANTABLE VENOUS ACCESS SYSTEM |
SIMS DELTEC, INC. |
| K083828 |
12/23/2008 |
SLEUTH AT IMPLANTABLE CARDIAC MONITORING SYSTEM -6 CM AND 8CM ANTENNA, PERSONAL DIAGNOSTICS MANAGER (PDM) ACCESSORY KIT |
TRANSOMA |
| K010426 |
02/13/2001 |
PROPORT PLASTIC VENOUS IMPLANTABLE ACCESS SYSTEMS PRE-ASSEMBLED WITH SILICONE CATHETER |
SIMS DELTEC, INC. |
| K962695 |
07/11/1996 |
PORT-A-CATH II VENOUS IMPLANTABLE ACCESS SYSTEMS PRECONNECTED WITH POLYURETHANE CATHETER |
SIMS DELTEC, INC. |
| K992697 |
08/11/1999 |
PORT-A-CATH II TRANS-ARTERIAL PERCUTANEOUS SYSTEM |
SIMS DELTEC, INC. |
| K992880 |
08/27/1999 |
P.A.S. PORT ELITE IMPLANTABLE VENOUS ACCESS SYSTEM |
SIMS DELTEC, INC. |
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