Maquet Cardiovascular, LLC: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “Maquet Cardiovascular, LLC” (first 2008, latest 2026), plus 1 PMA decision, across 5 product codes in 2 review panels. Median 510(k) review time under this name: 80 days. Since 2017 the median was 74 days, against 107 days for all cleared 510(k)s in the same product codes. 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 Getinge, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 14 |
| 2013 | 2 | 120 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 2 | 118 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 1 | 57 |
| 2020 | 1 | 271 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 1 | 81 |
| 2025 | 2 | 53 |
| 2026 | 1 | 266 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Maquet Cardiovascular, LLC took a median 74 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 107 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 8 | 8 |
| DSY | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter | 4 | 3 |
| GBX | Catheter, Irrigation | 1 | 1 |
| GCJ | Laparoscope, General & Plastic Surgery | 1 | 1 |
| MAL | Graft, Vascular, Synthetic/Biologic Composite | 1 | 1 |
Review panels
Most recent Maquet Cardiovascular, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252445 | Fusion Bioline Vascular Graft | DSY | 2026-04-27 | 266 |
| K251238 | Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000); Vasoview Hemopro 3 Endoscopic Vessel Harvesting System with Vasoshield (VH-6001); Vasoview Hemopro 3 Power Supply (VH-6010) | GEI | 2025-05-30 | 38 |
| K243918 | Vasoview Hemopro 3 Power Supply | GEI | 2025-02-26 | 68 |
| K233879 | Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000), Vasoview Hemopro 3 Endoscopic Vessel Harvesting System with Vasoshield (VH-6001), Vasoview Hemopro 3 Power Adapter (VH-6020) | GEI | 2024-02-27 | 81 |
| K191930 | 7 mm Extended Length Endoscope | GCJ | 2020-04-15 | 271 |
| K191947 | VASOVIEW HEMOPRO Extension Cable, VASOVIEW HEMOPRO 2 Extension Cable, Bipolar Extension Cable, Fixed Distance, Active Return Cord | GEI | 2019-09-17 | 57 |
| K153194 | VASOVIEW HemoPro Endoscopic Vessel Harvesting System | GEI | 2016-04-19 | 167 |
| K153523 | FUSION Vascular Graft | DSY | 2016-02-16 | 69 |
| K132743 | HARVESTING CANNULA | GEI | 2013-12-03 | 91 |
| K131778 | FUSION VASCULAR GRAFT AND FUSION BIOLINE VASCULAR GRAFT | DSY | 2013-11-14 | 150 |
4 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P840029 | PMA | MICROVEL(R) WITH HEMASHIELD | 1989-04-26 |
Recalls
271 product recalls in 42 recall events; 38 initiated in the last five years. Most recent: 2026-06-02.
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.
Device clinical trials
An industry sponsor named Maquet Cardiovascular, LLC is the lead sponsor of 4 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT07286890: Getinge's Beating Heart Product Family Post-Market Clinical Follow-up (PMCF) Study (Recruiting, started 2026-03-04)
- NCT01609270: CardioRoot Post-Marketing Surveillance Registry (Completed, started 2013-11)
- NCT01113892: Study Comparing Synthetic Vascular Grafts in Patients With Peripheral Artery Disease (PAD) Who Require Artery Bypass. (Completed, started 2010-05-17)
- NCT01710878: Performance and Safety of a Second Generation Antimicrobial Graft in Abdominal Position (Completed, started 2008-02)
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.
- Maquet Cardiopulmonary, AG (44 510(k)s)
- Maquet Critical Care AB (20 510(k)s)
- Maquet GmbH (4 510(k)s)
- Maquet S.A.S. (2 510(k)s)
- Maquet Critica Care AB (1 510(k)s)
- Maquet GmbH (A Getinge Group Company) (1 510(k)s)
- Maquet GmbH and Co. KG (1 510(k)s)
- Maquet S.A. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Maquet Cardiovascular, LLC?
FDA lists 14 510(k) clearances under the applicant name “Maquet Cardiovascular, LLC” (first 2008, latest 2026), plus 1 PMA decision, across 5 product codes in 2 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 Maquet Cardiovascular, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Maquet Cardiovascular, LLC is 80 days. Since 2017: 74 days, versus 107 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Maquet Cardiovascular, LLC?
The most frequent FDA product codes under this applicant name are GEI (Electrosurgical, Cutting & Coagulation & Accessories, 8); DSY (Prosthesis, Vascular Graft, Of 6mm And Greater Diameter, 4); GBX (Catheter, Irrigation, 1).
Next steps
- See all 14 Maquet Cardiovascular, LLC clearances with predicates and recalls
- Run predicate analysis for product code GEI, Maquet Cardiovascular, LLC'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.