FDA 510(k) Applications Submitted by SIMS DELTEC, INC.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K980583 |
02/17/1998 |
EXTENSION SET WITH 0.2U FILTER AND ANTI-SIPHON VALVE CADD ADMINISTRATION SET WITH 0.2U FILTER AND ANTI-SIPHON VALVE |
SIMS DELTEC, INC. |
| K960826 |
02/29/1996 |
CADD-PRIZM MODEL 6100 PUMP |
SIMS DELTEC, INC. |
| K960957 |
03/11/1996 |
EXTERNAL POWER SOURCE (EPS) SYSTEM, POWER PACK |
SIMS DELTEC, INC. |
| K955180 |
11/13/1995 |
CADD-PCA, -MICRO, -PRIZM AMBULATORY INFUSION PUMP |
SIMS DELTEC, INC. |
| K963009 |
08/02/1996 |
DELTEC SUBCUTANEOUS INFUSION SET |
SIMS DELTEC, INC. |
| K990083 |
01/11/1999 |
CADD ADMINISTRATION SET, CADD 250ML FLEXIBLE MEDICATION RESERVOIR, MODIFIED SECURIT SHELL, SECURITY SHELL ADAPTER |
SIMS DELTEC, INC. |
| K991255 |
04/13/1999 |
CADD-TPN ADMINISTRATION SET, MODEL 21-7071 |
SIMS DELTEC, INC. |
| K991301 |
04/16/1999 |
CADD-PRIZM HIGH VOLUME ADMINISTRATION SET WITH 1.2 U FILTER AND ADD-ON ANTI-SIPHON VALVE, CADD ADMINISTRATION SET WITH 1 |
SIMS DELTEC, INC. |
| K991599 |
05/10/1999 |
CADD ADMINISTRATION SET |
SIMS DELTEC, INC. |
| K982836 |
08/12/1998 |
CADD-LEGACY PLUS AMBULATORY INFUSION SYSTEM |
SIMS DELTEC, INC. |
| K982838 |
08/12/1998 |
CADD-LEGACY 1 AMBULATORY INFUSION SYSTEM MODEL NUMBER 6400 |
SIMS DELTEC, INC. |
| K982839 |
08/12/1998 |
CADD-LEGACY PCA AMBULATORY INFUSION SYSTEM, MODEL 6300 |
SIMS DELTEC, INC. |
| K973917 |
10/15/1997 |
CADD-DIPLOMAT PC COMMUNICATIONS SYSTEM AND THE CADD- AMBASSADOR PUMP COMMUNICATIONS SYSTEM |
SIMS DELTEC, INC. |
| K974013 |
10/22/1997 |
EXTENSION SET WITH MICROBORE TUBING, EXTENSION SET WITH MICROBORE TUBING AND 0.2 U FILTER, EXTENSION SET WITH MICROBORE |
SIMS DELTEC, INC. |
| K970269 |
01/23/1997 |
CLINICATH IR PERIPHERALLY INSERTED CATHETER |
SIMS 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. |
| K961580 |
04/24/1996 |
PORT-A-CATH P.A.S. PORT II IMPLANTABLE VENOUS ACCESS SYTEMS |
SIMS DELTEC, INC. |
| K973862 |
10/09/1997 |
PORT-A-CATH LOW-PROFILE IMPLANTABLE ACCESS SYSTEMS |
SIMS DELTEC, INC. |
| 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. |
| 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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