Sims Deltec, Inc.
St. Paul, MN, US
Sims Deltec, Inc. appears in FDA device records in St. Paul, MN. FDA records list 32 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 32
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 32 510(k) clearances for Sims Deltec, Inc. between 1995 and 2001. The busiest year on record is 1996, with 7. The most recent is 2001, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1995 | 4 |
| 1996 | 7 |
| 1997 | 3 |
| 1998 | 7 |
| 1999 | 7 |
| 2000 | 3 |
| 2001 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K010426 | PROPORT PLASTIC VENOUS IMPLANTABLE ACCESS SYSTEMS PRE-ASSEMBLED WITH SILICONE CATHETER | LJT | Substantially Equivalent | |
| K000842 | CADD-PRIZM PCS II MODEL 6101 AMBULATORY INFUSION SYSTEM | FRN | Substantially Equivalent | |
| K000942 | CADD CHECKVALVE ADMINISTRATION SET, MODEL 21-7090 | FPA | Substantially Equivalent | |
| K994216 | PLASTIC PORT IMPLANTABLE VENOUS ACCESS SYSTEM | LJT | Substantially Equivalent | |
| K992697 | PORT-A-CATH II TRANS-ARTERIAL PERCUTANEOUS SYSTEM | LJT | Substantially Equivalent | |
| K992880 | P.A.S. PORT ELITE IMPLANTABLE VENOUS ACCESS SYSTEM | LJT | Substantially Equivalent | |
| K991599 | CADD ADMINISTRATION SET | FPA | Substantially Equivalent | |
| K991301 | CADD-PRIZM HIGH VOLUME ADMINISTRATION SET WITH 1.2 U FILTER AND ADD-ON ANTI-SIPHON VALVE, CADD ADMINISTRATION SET WITH 1 | FPA | Substantially Equivalent | |
| K991255 | CADD-TPN ADMINISTRATION SET, MODEL 21-7071 | FPA | Substantially Equivalent | |
| K990083 | CADD ADMINISTRATION SET, CADD 250ML FLEXIBLE MEDICATION RESERVOIR, MODIFIED SECURIT SHELL, SECURITY SHELL ADAPTER | FPA | Substantially Equivalent | |
| K984055 | CLINICATH POLYFLOW POLYURETHANE PERIPHERALLY INSERTED CATHETERS | FOZ | Substantially Equivalent | |
| K982838 | CADD-LEGACY 1 AMBULATORY INFUSION SYSTEM MODEL NUMBER 6400 | FRN | Substantially Equivalent | |
| K982839 | CADD-LEGACY PCA AMBULATORY INFUSION SYSTEM, MODEL 6300 | MEA | Substantially Equivalent | |
| K982836 | CADD-LEGACY PLUS AMBULATORY INFUSION SYSTEM | FRN | Substantially Equivalent | |
| K980583 | EXTENSION SET WITH 0.2U FILTER AND ANTI-SIPHON VALVE CADD ADMINISTRATION SET WITH 0.2U FILTER AND ANTI-SIPHON VALVE | FPA | Substantially Equivalent | |
| K974661 | 0.2 U BACTERIAL FILTER | FPB | Substantially Equivalent | |
| K974471 | PORT-A-CATH- II DUAL-LUMEN LOW PROFILE SYSTEM, PORT-A-CATH II DUAL LUMEN LOW PROFILE SYSTEM WITH INTRODUCER SET, PORT-A | LJT | Substantially Equivalent | |
| K973917 | CADD-DIPLOMAT PC COMMUNICATIONS SYSTEM AND THE CADD- AMBASSADOR PUMP COMMUNICATIONS SYSTEM | FRN | Substantially Equivalent | |
| K973862 | PORT-A-CATH LOW-PROFILE IMPLANTABLE ACCESS SYSTEMS | LJT | Substantially Equivalent | |
| K974013 | EXTENSION SET WITH MICROBORE TUBING, EXTENSION SET WITH MICROBORE TUBING AND 0.2 U FILTER, EXTENSION SET WITH MICROBORE | FPA | Substantially Equivalent | |
| K970269 | CLINICATH IR PERIPHERALLY INSERTED CATHETER | LJS | Substantially Equivalent | |
| K963009 | DELTEC SUBCUTANEOUS INFUSION SET | FPA | Substantially Equivalent | |
| K962695 | PORT-A-CATH II VENOUS IMPLANTABLE ACCESS SYSTEMS PRECONNECTED WITH POLYURETHANE CATHETER | LJT | Substantially Equivalent | |
| K961580 | PORT-A-CATH P.A.S. PORT II IMPLANTABLE VENOUS ACCESS SYTEMS | LJT | Substantially Equivalent | |
| K960826 | CADD-PRIZM MODEL 6100 PUMP | FRN | Substantially Equivalent | |
| K960957 | EXTERNAL POWER SOURCE (EPS) SYSTEM, POWER PACK | FRN | Substantially Equivalent | |
| K955180 | CADD-PCA, -MICRO, -PRIZM AMBULATORY INFUSION PUMP | FRN | Substantially Equivalent | |
| K955407 | PORT-A-CATH DUAL LUMEN IMPLANTABLE VENOUS | LJT | Substantially Equivalent | |
| K954870 | SIMS DELTEC ANTI-SIPHON VALVE | FPA | Substantially Equivalent | |
| K935767 | SIMS SILO NEEDLE DE-ACCESS ENCLOSURE | LJT | Substantially Equivalent | |
| K951078 | CATHETER, INTRAVASCULAR OR PERCUTANEOUS | LJS | Substantially Equivalent | |
| K950284 | SIMS DELTEC, INC. CATHETER REPLACEMENT CONNECTOR | FOZ | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain