Guidant Cardiac and Vascular Surgery: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Guidant Cardiac and Vascular Surgery” (first 1997, latest 2002), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 90 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 |
|---|---|---|---|
| DQY | Catheter, Percutaneous | 2 | 2 |
| DYB | Introducer, Catheter | 2 | 2 |
| DQO | Catheter, Intravascular, Diagnostic | 1 | 1 |
| DRE | Dilator, Vessel, For Percutaneous Catheterization | 1 | 1 |
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | 1 | 1 |
Review panels
- Cardiovascular (6)
- Radiology (1)
Most recent Guidant Cardiac and Vascular Surgery 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K003889 | ANCURE SHEATH MODEL # 40315, 40320, 40325 | DYB | 2002-01-24 | 402 |
| K001694 | GUIDANT RETRIEVER DEVICE | DQY | 2001-05-15 | 347 |
| K003495 | ANCURE LLIAC BALLOON CATHETER | DQY | 2001-02-07 | 86 |
| K002676 | ENDOVANCE DUALPASS TEAR-AWAY SHEATH INTRODUCER | DYB | 2000-10-30 | 63 |
| K970470 | EVT EXPANDABLE SHEATH | DRE | 1997-07-31 | 174 |
| K970469 | EVT ANGIOSCALE ANGIOGRAPHIC CATHETER | DQO | 1997-05-08 | 90 |
| K970608 | EVT MARKER BOARD | JAA | 1997-04-21 | 62 |
Recalls
openFDA lists no recalls under a recalling firm named Guidant Cardiac and Vascular 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 Corporation, Cardiac Surgery (8 510(k)s)
- Guidant Endovascular Solutions, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Guidant Cardiac and Vascular Surgery?
FDA lists 7 510(k) clearances under the applicant name “Guidant Cardiac and Vascular Surgery” (first 1997, latest 2002), 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 Guidant Cardiac and Vascular Surgery?
The median time from FDA receipt to decision across 510(k)s cleared under the name Guidant Cardiac and Vascular Surgery is 90 days.
Which FDA product codes appear under Guidant Cardiac and Vascular Surgery?
The most frequent FDA product codes under this applicant name are DQY (Catheter, Percutaneous, 2); DYB (Introducer, Catheter, 2); DQO (Catheter, Intravascular, Diagnostic, 1).
Next steps
- See all 7 Guidant Cardiac and Vascular Surgery clearances with predicates and recalls
- Run predicate analysis for product code DQY, Guidant Cardiac and Vascular 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.