Pharmacia Deltec, Inc.: FDA clearances and approvals
Pharmacia Deltec, Inc. has 43 FDA 510(k) clearances (first 1987, latest 1995), across 10 product codes in 3 review panels. Median 510(k) review time: 97 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FRN | Pump, Infusion | 10 | 10 |
| FPA | Set, Administration, Intravascular | 8 | 8 |
| LJS | Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | 7 | 7 |
| LJT | Port & Catheter, Implanted, Subcutaneous, Intravascular | 7 | 7 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 4 | 4 |
| LKG | Port & Catheter, Implanted, Subcutaneous, Intraventricular | 2 | 2 |
| MEA | Pump, Infusion, Pca | 2 | 2 |
| FIH | Pump, Infusion Or Syringe, Extra-Luminal | 1 | 1 |
| KGX | Tape And Bandage, Adhesive | 1 | 1 |
| LLD | Port & Catheter, Implanted, Subcutaneous, Intraperitoneal | 1 | 1 |
Review panels
Most recent Pharmacia Deltec, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K943310 | MODEL 6100 AMBULATORY INFUSION SYSTEM | MEA | 1995-02-21 | 225 |
| K942046 | PHARMACIA DELTEC EXTENSION SET WITH ANTI-SIPHON VALVE | FPA | 1994-10-04 | 159 |
| K942161 | LOCKBOX | FRN | 1994-08-02 | 90 |
| K942024 | PORT-A-CATH LOW PROFILE IMPLANTABLE VENOUS ACCESS SYSTEM | LJT | 1994-07-26 | 91 |
| K941445 | EXTENSION SET WITH ANTI-SIPHON VALVE | FPA | 1994-06-29 | 97 |
| K931073 | CATH-FINDER | FOZ | 1994-05-05 | 429 |
| K932464 | PERIPHERALLYINSRTED VENOUS CATH. ALTERNATE CATH. | LJS | 1994-05-02 | 346 |
| K932433 | PHERIPHERALLY INSERTED VENOUS CATHETER-Y SITE | LJS | 1994-05-02 | 347 |
| K932430 | DUAL LUMEN PERIPHERALLY INSERTED VENOUS CATHETER | LJS | 1994-05-02 | 347 |
| K932211 | PROCEDURAL TRAY FOR PERIPHERALLY INSERTED VENOUS | LJS | 1994-05-02 | 360 |
33 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Pharmacia Deltec, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Pharmacia Deltec, Inc.'s product codes (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via FRN)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via FRN)
- E0785 — Implantable intraspinal (epidural/intrathecal) catheter used with implantable infusion pump, replacement (via FRN)
Frequently asked questions
How many FDA 510(k) clearances does Pharmacia Deltec, Inc. have?
Pharmacia Deltec, Inc. has 43 FDA 510(k) clearances (first 1987, latest 1995), across 10 product codes in 3 review panels.
How long does FDA take to clear Pharmacia Deltec, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Pharmacia Deltec, Inc.'s cleared 510(k)s is 97 days.
What devices does Pharmacia Deltec, Inc. make?
Its most frequent FDA product codes are FRN (Pump, Infusion, 10); FPA (Set, Administration, Intravascular, 8); LJS (Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days, 7).
Has Pharmacia Deltec, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Pharmacia Deltec, Inc. Related entities may recall under other names.
Next steps
- See all 43 Pharmacia Deltec, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FRN, Pharmacia Deltec, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.