Medical Device Manufacturer · US , St. Paul , MN

Sims Deltec, Inc.

32 submissions · 32 cleared · Since 1995
32
Total
32
Cleared
0
Denied

Sims Deltec, Inc. — FDA 510(k) Submissions

Sims Deltec, Inc. has submitted 32 FDA 510(k) premarket notifications since 1995, of which 32 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Port & Catheter, Implanted, Subcutaneous, Intravascular, Set, Administration, Intravascular, Pump, Infusion, Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days, Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days . Use the specialty filter in the sidebar to narrow results.

32 devices
1–25 of 32
PROPORT PLASTIC VENOUS IMPLANTABLE ACCESS SYSTEMS PRE-ASSEMBLED WITH SILICONE CATHETER
K010426 · LJT Port & Catheter,... · General Hospital
Mar 2001 23d
CADD-PRIZM PCS II MODEL 6101 AMBULATORY INFUSION SYSTEM
K000842 · FRN Pump, Infusion · General Hospital
Jun 2000 85d
CADD CHECKVALVE ADMINISTRATION SET, MODEL 21-7090
K000942 · FPA Set, Administration,... · General Hospital
Apr 2000 35d
PLASTIC PORT IMPLANTABLE VENOUS ACCESS SYSTEM
K994216 · LJT Port & Catheter,... · General Hospital
Jan 2000 43d
PORT-A-CATH II TRANS-ARTERIAL PERCUTANEOUS SYSTEM
K992697 · LJT Port & Catheter,... · General Hospital
Nov 1999 99d
P.A.S. PORT ELITE IMPLANTABLE VENOUS ACCESS SYSTEM
K992880 · LJT Port & Catheter,... · General Hospital
Oct 1999 53d
CADD ADMINISTRATION SET
K991599 · FPA Set, Administration,... · General Hospital
Jun 1999 36d
CADD-TPN ADMINISTRATION SET, MODEL 21-7071
K991255 · FPA Set, Administration,... · General Hospital
Jun 1999 57d
CADD-PRIZM HIGH VOLUME ADMINISTRATION SET WITH 1.2 U FILTER AND ADD-ON ANTI-SIPHON VALVE, CADD ADMINISTRATION SET WITH 1
K991301 · FPA Set, Administration,... · General Hospital
Jun 1999 54d
CADD ADMINISTRATION SET, CADD 250ML FLEXIBLE MEDICATION RESERVOIR, MODIFIED SECURIT SHELL, SECURITY SHELL ADAPTER
K990083 · FPA Set, Administration,... · General Hospital
Feb 1999 32d
CLINICATH POLYFLOW POLYURETHANE PERIPHERALLY INSERTED CATHETERS
K984055 · FOZ Catheter, Intravascular,... · General Hospital
Jan 1999 77d
CADD-LEGACY 1 AMBULATORY INFUSION SYSTEM MODEL NUMBER 6400
K982838 · FRN Pump, Infusion · General Hospital
Nov 1998 84d
CADD-LEGACY PLUS AMBULATORY INFUSION SYSTEM
K982836 · FRN Pump, Infusion · General Hospital
Nov 1998 82d
CADD-LEGACY PCA AMBULATORY INFUSION SYSTEM, MODEL 6300
K982839 · MEA Pump, Infusion, Pca · General Hospital
Nov 1998 82d
EXTENSION SET WITH 0.2U FILTER AND ANTI-SIPHON VALVE CADD ADMINISTRATION SET WITH 0.2U FILTER AND ANTI-SIPHON VALVE
K980583 · FPA Set, Administration,... · General Hospital
Apr 1998 69d
0.2 U BACTERIAL FILTER
K974661 · FPB Filter, Infusion Line · General Hospital
Feb 1998 58d
PORT-A-CATH- II DUAL-LUMEN LOW PROFILE SYSTEM, PORT-A-CATH II DUAL LUMEN LOW PROFILE SYSTEM WITH INTRODUCER SET, PORT-A
K974471 · LJT Port & Catheter,... · General Hospital
Jan 1998 57d
CADD-DIPLOMAT PC COMMUNICATIONS SYSTEM AND THE CADD- AMBASSADOR PUMP COMMUNICATIONS SYSTEM
K973917 · FRN Pump, Infusion · General Hospital
Jan 1998 86d
PORT-A-CATH LOW-PROFILE IMPLANTABLE ACCESS SYSTEMS
K973862 · LJT Port & Catheter,... · General Hospital
Dec 1997 81d
EXTENSION SET WITH MICROBORE TUBING, EXTENSION SET WITH MICROBORE TUBING AND 0.2 U FILTER, EXTENSION SET WITH MICROBORE
K974013 · FPA Set, Administration,... · General Hospital
Dec 1997 56d
CLINICATH IR PERIPHERALLY INSERTED CATHETER
K970269 · LJS Catheter, Intravascular,... · General Hospital
Jun 1997 154d
DELTEC SUBCUTANEOUS INFUSION SET
K963009 · FPA Set, Administration,... · General Hospital
Oct 1996 77d
PORT-A-CATH II VENOUS IMPLANTABLE ACCESS SYSTEMS PRECONNECTED WITH POLYURETHANE CATHETER
K962695 · LJT Port & Catheter,... · General Hospital
Oct 1996 82d
PORT-A-CATH P.A.S. PORT II IMPLANTABLE VENOUS ACCESS SYTEMS
K961580 · LJT Port & Catheter,... · General Hospital
Sep 1996 149d
CADD-PRIZM MODEL 6100 PUMP
K960826 · FRN Pump, Infusion · General Hospital
Aug 1996 176d
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