Guidant Cardiac and Vascular Surgery
Menlo Park, CA, US
Guidant Cardiac and Vascular Surgery appears in FDA device records in Menlo Park, CA. FDA records list 7 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 7
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 7 510(k) clearances for Guidant Cardiac and Vascular Surgery between 1997 and 2002. The busiest year on record is 1997, with 3. The most recent is 2002, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1997 | 3 |
| 2000 | 1 |
| 2001 | 2 |
| 2002 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K003889 | ANCURE SHEATH MODEL # 40315, 40320, 40325 | DYB | Substantially Equivalent | |
| K001694 | GUIDANT RETRIEVER DEVICE | DQY | Substantially Equivalent | |
| K003495 | ANCURE LLIAC BALLOON CATHETER | DQY | Substantially Equivalent | |
| K002676 | ENDOVANCE DUALPASS TEAR-AWAY SHEATH INTRODUCER | DYB | Substantially Equivalent | |
| K970470 | EVT EXPANDABLE SHEATH | DRE | Substantially Equivalent | |
| K970469 | EVT ANGIOSCALE ANGIOGRAPHIC CATHETER | DQO | Substantially Equivalent | |
| K970608 | EVT MARKER BOARD | JAA | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain