Guidant Corporation, Cardiac Surgery: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Guidant Corporation, Cardiac Surgery” (first 2002, latest 2008), across 6 product codes in 3 review panels. Median 510(k) review time under this name: 50 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
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 |
|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | 2 | 2 |
| NHW | Electrode, Pacing And Cardioversion, Temporary, Epicardial | 2 | 2 |
| DXC | Clamp, Vascular | 1 | 1 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 | 1 |
| HET | Laparoscope, Gynecologic (And Accessories) | 1 | 1 |
| NEY | System, Ablation, Microwave And Accessories | 1 | 1 |
Review panels
Most recent Guidant Corporation, Cardiac Surgery 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K080169 | HEARTSTRING III PROXIMAL SEAL SYSTEM | DXC | 2008-02-08 | 15 |
| K041340 | GUIDANT MICROWAVE ABLATION SYSTEM | NEY | 2004-07-28 | 69 |
| K023630 | ESSEX ASPIRATION/IRRIGATION INSTRUMENT WITH POSITIONING GUIDE, MODEL SY-1400 | GCJ | 2003-02-20 | 115 |
| K024071 | GUIDANT SYNCRUS INTERNAL CARDIOVERSION SYSTEM | NHW | 2003-02-14 | 66 |
| K023629 | ESSEX DISSECTION CANNULA, MODEL SXD-1100, ESSEX DISSECTION TIP, MODEL SXD-1200 | GCJ | 2002-11-12 | 15 |
| K022718 | VASOVIEW 6 HARVESTING CANNULA, MODELS VH-2000, VH-2001 & VH-2002 | GEI | 2002-08-28 | 13 |
| K020701 | SYNCRUS INTERNAL CARDIOVERSION SYSTEM | NHW | 2002-05-24 | 81 |
| K020143 | VASOVIEW 5 HARVESTING CANNULA | HET | 2002-02-20 | 35 |
Recalls
openFDA lists no recalls under a recalling firm named Guidant Corporation, Cardiac Surgery.
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.
- Guidant Corp. (86 510(k)s)
- Guidant Cardiac and Vascular Surgery (7 510(k)s)
- Guidant Endovascular Solutions, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Guidant Corporation, Cardiac Surgery?
FDA lists 8 510(k) clearances under the applicant name “Guidant Corporation, Cardiac Surgery” (first 2002, latest 2008), across 6 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 Guidant Corporation, Cardiac Surgery?
The median time from FDA receipt to decision across 510(k)s cleared under the name Guidant Corporation, Cardiac Surgery is 50 days.
Which FDA product codes appear under Guidant Corporation, Cardiac Surgery?
The most frequent FDA product codes under this applicant name are GCJ (Laparoscope, General & Plastic Surgery, 2); NHW (Electrode, Pacing And Cardioversion, Temporary, Epicardial, 2); DXC (Clamp, Vascular, 1).
Next steps
- See all 8 Guidant Corporation, Cardiac Surgery clearances with predicates and recalls
- Run predicate analysis for product code GCJ, Guidant Corporation, Cardiac Surgery'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.