Sims Deltec, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
32
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K010426PROPORT PLASTIC VENOUS IMPLANTABLE ACCESS SYSTEMS PRE-ASSEMBLED WITH SILICONE CATHETERMarch 8, 2001
K000842CADD-PRIZM PCS II MODEL 6101 AMBULATORY INFUSION SYSTEMJune 8, 2000
K000942CADD CHECKVALVE ADMINISTRATION SET, MODEL 21-7090April 27, 2000
K994216PLASTIC PORT IMPLANTABLE VENOUS ACCESS SYSTEMJanuary 27, 2000
K992697PORT-A-CATH II TRANS-ARTERIAL PERCUTANEOUS SYSTEMNovember 18, 1999
K992880P.A.S. PORT ELITE IMPLANTABLE VENOUS ACCESS SYSTEMOctober 19, 1999
K991599CADD ADMINISTRATION SETJune 15, 1999
K991301CADD-PRIZM HIGH VOLUME ADMINISTRATION SET WITH 1.2 U FILTER AND ADD-ON ANTI-SIPHON VALVE, CADD ADMINJune 9, 1999
K991255CADD-TPN ADMINISTRATION SET, MODEL 21-7071June 9, 1999
K990083CADD ADMINISTRATION SET, CADD 250ML FLEXIBLE MEDICATION RESERVOIR, MODIFIED SECURIT SHELL, SECURITY February 12, 1999
K984055CLINICATH POLYFLOW POLYURETHANE PERIPHERALLY INSERTED CATHETERSJanuary 29, 1999
K982838CADD-LEGACY 1 AMBULATORY INFUSION SYSTEM MODEL NUMBER 6400November 4, 1998
K982839CADD-LEGACY PCA AMBULATORY INFUSION SYSTEM, MODEL 6300November 2, 1998
K982836CADD-LEGACY PLUS AMBULATORY INFUSION SYSTEMNovember 2, 1998
K980583EXTENSION SET WITH 0.2U FILTER AND ANTI-SIPHON VALVE CADD ADMINISTRATION SET WITH 0.2U FILTER AND ANApril 27, 1998
K9746610.2 U BACTERIAL FILTERFebruary 11, 1998
K974471PORT-A-CATH- II DUAL-LUMEN LOW PROFILE SYSTEM, PORT-A-CATH II DUAL LUMEN LOW PROFILE SYSTEM WITH INTJanuary 22, 1998
K973917CADD-DIPLOMAT PC COMMUNICATIONS SYSTEM AND THE CADD- AMBASSADOR PUMP COMMUNICATIONS SYSTEMJanuary 9, 1998
K973862PORT-A-CATH LOW-PROFILE IMPLANTABLE ACCESS SYSTEMSDecember 29, 1997
K974013EXTENSION SET WITH MICROBORE TUBING, EXTENSION SET WITH MICROBORE TUBING AND 0.2 U FILTER, EXTENSIONDecember 17, 1997