Carbomedics, Inc.: FDA filings under this applicant name
FDA lists 22 510(k) clearances under the applicant name “Carbomedics, Inc.” (first 1979, latest 1997), plus 1 PMA decision, across 14 product codes in 3 review panels. Median 510(k) review time under this name: 84 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 LivaNova, 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 |
|---|---|---|---|
| DSY | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter | 3 | 3 |
| DTJ | Holder, Heart-Valve, Prosthesis | 3 | 3 |
| LYC | Bone Grafting Material, Synthetic | 3 | 3 |
| DTI | Sizer, Heart-Valve, Prosthesis | 2 | 2 |
| DZE | Implant, Endosseous, Root-Form | 2 | 2 |
| MOP | Rotator, Prosthetic Heart Valve | 2 | 2 |
| DXO | Transducer, Pressure, Catheter Tip | 1 | 1 |
| JDG | Prosthesis, Hip, Femoral Component, Cemented, Metal | 1 | 1 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 1 | 1 |
| JDL | Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) | 1 | 1 |
Plus 4 more product codes.
Review panels
- Cardiovascular (13)
- Dental (5)
- Orthopedic (5)
Most recent Carbomedics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K970375 | ANNULOFLO SYSTEM | KRH | 1997-07-25 | 172 |
| K964665 | VASCUTEK GELWEAVE VASCULAR GRAFT (BIFURCATED CONFIGURATION) | DSY | 1997-02-19 | 90 |
| K962154 | CARBOMEDICS HANDLE | DTJ | 1996-08-27 | 84 |
| K960923 | CARBOMEDICS MITRAL ROTATOR | MOP | 1996-04-29 | 54 |
| K960706 | VASCUTEK VASCUSOFT PLUS VASCULAR GRAFT | DSY | 1996-04-25 | 64 |
| K960169 | CARBOMEDICS VALVE TESTER | DTJ | 1996-04-15 | 90 |
| K955588 | VASCUTEK GRAFT SIZER SET | DSY | 1996-03-07 | 91 |
| K952184 | CARBOMEDICS SUPRA-ANNULAR VALVE SIZER | DTI | 1995-11-29 | 204 |
| K951368 | CARBOMEDICS EXENDED MITRAL ROTATOR | MOP | 1995-06-20 | 85 |
| K942736 | CARBOMEDICS(R) PROSTHETIC HEART VALVE HOLDER HANDLE | DTJ | 1994-07-06 | 26 |
12 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P890045 | PMA | GELSEAL TM TRIAXIAL VASCULAR GRAFT | 1993-01-11 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2002-04-30.
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Carbomedics, Inc.?
FDA lists 22 510(k) clearances under the applicant name “Carbomedics, Inc.” (first 1979, latest 1997), plus 1 PMA decision, across 14 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 Carbomedics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Carbomedics, Inc. is 84 days.
Which FDA product codes appear under Carbomedics, Inc.?
The most frequent FDA product codes under this applicant name are DSY (Prosthesis, Vascular Graft, Of 6mm And Greater Diameter, 3); DTJ (Holder, Heart-Valve, Prosthesis, 3); LYC (Bone Grafting Material, Synthetic, 3).
Next steps
- See all 22 Carbomedics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DSY, Carbomedics, Inc.'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.