Baxter Edwards: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Baxter Edwards” (first 1993, latest 2000), across 10 product codes in 3 review panels. Median 510(k) review time under this name: 148 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Edwards Lifesciences, based on public ownership records.
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 |
|---|---|---|---|
| LYK | Angioscope | 2 | 2 |
| DSY | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter | 1 | 1 |
| DTJ | Holder, Heart-Valve, Prosthesis | 1 | 1 |
| DYB | Introducer, Catheter | 1 | 1 |
| DYG | Catheter, Flow Directed | 1 | 1 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 1 | 1 |
| HCG | Device, Neurovascular Embolization | 1 | 1 |
| KRH | Ring, Annuloplasty | 1 | 1 |
| MCW | Catheter, Peripheral, Atherectomy | 1 | 1 |
| MGZ | Valvulotome | 1 | 1 |
Review panels
- Cardiovascular (9)
- General Hospital (1)
- Neurology (1)
Most recent Baxter Edwards 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K993816 | BAXTER PERCUTANEOUS MECHANICAL THROMBECTOMY (PMT) DEVICE, MODELS PMT0606FD AND PMT1206FD | MCW | 2000-05-04 | 176 |
| K981909 | BAXTER HEMOSTASIS VALVE INTRODUCERS | DYB | 1998-11-24 | 176 |
| K980487 | CARPENTER-EDWARDS CLASSIC RING WITH DURAFLO TREATMENT MODELS 4425 (MITRAL) AND 4525 (TRICUSPID), CARPENTER-EDWARDS PHYSM | KRH | 1998-07-07 | 148 |
| K965137 | FOGARTY VALVULOTOME MODEL 700091 | MGZ | 1997-06-04 | 163 |
| K964021 | INTRAMED SIDE BRANCH OCCLUSION (SBO) SYSTEM (700095 AND 700099) | HCG | 1997-03-27 | 171 |
| K955839 | MULTI-MED MULTI-LUMEN CENTRAL VENOUS CATHETER | FOZ | 1996-03-25 | 90 |
| K952638 | 4.5F IMAGECATH CORONARY ANGIOSCOPE, MODEL COV45 [SUBSEQUENTLY REFERRED TO AS THE MODIFIED ANGIOSCOPE[ | LYK | 1995-07-28 | 49 |
| K944214 | BAXTER HANDLE MODEL 1150 | DTJ | 1995-02-10 | 165 |
| K944858 | BAXTER EPTFE EXTERNALLY SUPPORTED VASCULAR GRAFTS | DSY | 1995-01-05 | 94 |
| K940795 | SWAN-GANZ CC0/SVO2 THERMODILUTION CATHETER | DYG | 1994-05-24 | 91 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Baxter Edwards.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Baxter Healthcare Corp (568 510(k)s)
- Baxter Diagnostics, Inc. (72 510(k)s)
- Baxter Bentley Laboratories, Inc. (3 510(k)s)
- Baxter Healthcare Corportation (3 510(k)s)
- Baxter Healthcare Corporation - Renal Division (2 510(k)s)
- Baxter Corp. (1 510(k)s)
- Baxter Centre For Medical Research (1 510(k)s)
- Baxter Healthcare Corp., Bioscience (1 510(k)s)
- Baxter Healthcare Corp/ Excel Medical (1 510(k)s)
- Baxter Healthcare Corproration (1 510(k)s)
- Baxter Interwoven Offsite (1 510(k)s)
- Baxter Bio Science (0 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Baxter Edwards?
FDA lists 11 510(k) clearances under the applicant name “Baxter Edwards” (first 1993, latest 2000), across 10 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Baxter Edwards?
The median time from FDA receipt to decision across 510(k)s cleared under the name Baxter Edwards is 148 days.
Which FDA product codes appear under Baxter Edwards?
The most frequent FDA product codes under this applicant name are LYK (Angioscope, 2); DSY (Prosthesis, Vascular Graft, Of 6mm And Greater Diameter, 1); DTJ (Holder, Heart-Valve, Prosthesis, 1).
Next steps
- See all 11 Baxter Edwards clearances with predicates and recalls
- Run predicate analysis for product code LYK, Baxter Edwards's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.