Pharmacia Deltec, Inc.
St. Paul, MN, US
Pharmacia Deltec, Inc. appears in FDA device records in St. Paul, MN. FDA records list 43 510(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
- 43
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 43 510(k) clearances for Pharmacia Deltec, Inc. between 1987 and 1995. The busiest year on record is 1994, with 16. The most recent is 1995, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1987 | 5 |
| 1988 | 6 |
| 1989 | 4 |
| 1990 | 8 |
| 1991 | 1 |
| 1993 | 2 |
| 1994 | 16 |
| 1995 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K943310 | MODEL 6100 AMBULATORY INFUSION SYSTEM | MEA | Substantially Equivalent - Subject to Tracking Reg. | |
| K942046 | PHARMACIA DELTEC EXTENSION SET WITH ANTI-SIPHON VALVE | FPA | Substantially Equivalent | |
| K942161 | LOCKBOX | FRN | Substantially Equivalent - Subject to Tracking Reg. | |
| K942024 | PORT-A-CATH LOW PROFILE IMPLANTABLE VENOUS ACCESS SYSTEM | LJT | Substantially Equivalent | |
| K941445 | EXTENSION SET WITH ANTI-SIPHON VALVE | FPA | Substantially Equivalent | |
| K931073 | CATH-FINDER | FOZ | Substantially Equivalent | |
| K932464 | PERIPHERALLYINSRTED VENOUS CATH. ALTERNATE CATH. | LJS | Unknown | |
| K932433 | PHERIPHERALLY INSERTED VENOUS CATHETER-Y SITE | LJS | Unknown | |
| K932430 | DUAL LUMEN PERIPHERALLY INSERTED VENOUS CATHETER | LJS | Unknown | |
| K932211 | PROCEDURAL TRAY FOR PERIPHERALLY INSERTED VENOUS | LJS | Substantially Equivalent | |
| K932198 | PHARMACIA DELTEC PERIPHERALLY INSERTED VENOUS CATH | LJS | Unknown | |
| K931113 | CADD-TPN(TM) AMBULATORY INFUSION SYSTEM | FIH | Substantially Equivalent | |
| K926544 | PHARMACIA DELTEC PERIPHERALLY INSERTED VENOUS CATH | FOZ | Substantially Equivalent | |
| K933390 | REMOTE RESERVOIR ADAPTER(TM) CASSETTE WITH BAG | FPA | Substantially Equivalent | |
| K932841 | PORT-A-CATH DUAL LUMEN IMPLANTABLE VENOUS ACCESS | LJT | Substantially Equivalent | |
| K932840 | PORT-A-CATH IMPLANTABLE VASCULAR ACCESS SYSTEM | LJT | Substantially Equivalent | |
| K932095 | PORT-A-CATH DUAL LUMEN IMPLANTABLE VENOUS ACCESS S | LJT | Substantially Equivalent | |
| K931132 | CADD-MICRO(TM) MODEL 5900 AMBULATORY INFUSION PUMP | FRN | Substantially Equivalent | |
| K923019 | PHARMACIA DELTEC WINGED INFUSION SET | LJT | Substantially Equivalent | |
| K911791 | CDD-PCA(TM) MODEL 5800R AMBULATORY INFUSION PUMP | MEA | Substantially Equivalent | |
| K904150 | CATH-FINDER(TM) CATHETER TRACKING SYSTEM | FOZ | Substantially Equivalent | |
| K904334 | PERCUTANEOUS INTRAVENOUS CATHETER REPAIR KIT | LJS | Unknown | |
| K903220 | PORT-A-CATH IMPLANTABLE DRUG DELIVERY SYSTEM | LJT | Substantially Equivalent | |
| K902374 | CADD-TPN MODEL 5700 AMBULATORY INFUSION SYSTEM | FRN | Substantially Equivalent | |
| K896075 | CADD-PCA AMBULATORY INFUSION PUMPS | FRN | Substantially Equivalent | |
| K895644 | CADD-PCA AMBULATORY INFUSION PUMPS | FRN | Substantially Equivalent | |
| K900888 | LOCKBOX | FRN | Substantially Equivalent | |
| K896346 | GRIPPER PORT-A-CATH NEEDLE WITH STOPCOCK | FPA | Substantially Equivalent | |
| K895712 | PERCUTANEOUS INTRAVENOUS CATHETERS | LJS | Substantially Equivalent | |
| K895046 | REMOTE RESERVOIR ADAPTER CASSETTE W/BAG SPIKE | FPA | Substantially Equivalent | |
| K890062 | CADD-PCA MODEL 5800 AMBULATORY INFUSION PUMP | FRN | Substantially Equivalent | |
| K884701 | CATH-FINDER SYSTEM | FOZ | Substantially Equivalent | |
| K881690 | PORT-A-CATH PORTAL INTRODUCER FORCEPS | LKG | Substantially Equivalent | |
| K881493 | PORT-A-CATH IMPLANTABLE ACCESS SYSTEM - KIT CONF. | LKG | Substantially Equivalent | |
| K880204 | CADD-TPA(TM) MODEL 5600 AMBULATORY INFUSION PUMP | FRN | Substantially Equivalent | |
| K875276 | PORT-A-CATH(R) IMPLANTABLE DRUG DELIVERY SYSTEM | LJT | Substantially Equivalent | |
| K880072 | PORT-A-CATH IMPLANTABLE DRUG DELIVERY SYSTEM | LLD | Substantially Equivalent | |
| K874649 | CADD-PLUS(TM) MODEL 5400 AMBULATORY INFUSION PUMP | FRN | Substantially Equivalent | |
| K873885 | PHARMACIA DELTEC SUBCUTANEOUS INFUSION SET | FPA | Substantially Equivalent | |
| K873876 | PHARMACIA DELTEC BAG SPIKE SET | FPA | Substantially Equivalent | |
| K873042 | MODEL 1330 EXTENSION SET | FPA | Substantially Equivalent | |
| K872821 | INFUSION PUMP ENCLOSURE | FRN | Substantially Equivalent | |
| K870900 | THE GRIPPER SEAL(TM) | KGX | Substantially Equivalent for Some Indications |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- LJSCatheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
- FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- LLDPort & Catheter, Implanted, Subcutaneous, Intraperitoneal
- LJTPort & Catheter, Implanted, Subcutaneous, Intravascular
- LKGPort & Catheter, Implanted, Subcutaneous, Intraventricular
- FRNPump, Infusion
- FIHPump, Infusion Or Syringe, Extra-Luminal
- MEAPump, Infusion, Pca
- FPASet, Administration, Intravascular
- KGXTape And Bandage, Adhesive
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