Medtronic Cardiac Surgical Products
Grand Rapids, MI, US
Medtronic Cardiac Surgical Products appears in FDA device records in Grand Rapids, MI. 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 Medtronic Cardiac Surgical Products between 2000 and 2003. The busiest year on record is 2001, with 4. The most recent is 2003, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2000 | 2 |
| 2001 | 4 |
| 2003 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K022272 | MALLEABLE SINGLE STAGE VENOUS CANNULA, MODELS 68112-68140 (15 TOTAL CODES) | DWF | Substantially Equivalent | |
| K013013 | MEDTRONIC DLP ARTERIAL CANNULA WITH 3D TIP - 22 FR. | DWF | Substantially Equivalent | |
| K012143 | 24 FR. LEFT HEART VENT CATHETER WITH PRESSURE MONITORING LINE, MODEL 12524 | DRA | Substantially Equivalent | |
| K010737 | SELECT CAP ARTERIAL CANNULA WITH PRESSURE MONITORING LINE, MODEL 78818,78820,78822,78824,78918,78920,78922,78924 | DWF | Substantially Equivalent | |
| K000776 | MEDTRONIC DLP ARTERIAL CANNULAE WITH 3D TIP | DWF | Substantially Equivalent | |
| K994171 | MEDTRONIC AORTOCORONARY SHUNT AND SEPARATELY PACKAGED ARTERIOTOMY CANNULAE | DWF | Substantially Equivalent | |
| K000274 | EOPA ELONGATED ONE-PIECE ARTERIAL CANNULA WITH GUIDEWIRE | DWF | 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