510(k) K834039 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
INFANT VENT CATHETER 12001 W/SIDE VENT
| Applicant | Dlp, Inc., Grand Rapids MI, US |
| Decision | Substantially Equivalent, Jan 3, 1984 |
| Received | Nov 23, 1983 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K834039
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 3, 2025 | Medtronic Perfusion Systems DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12113 LV VENT 13FR, Model Number 12113 Open, Classified |
DWF | None listed |
| Sep 3, 2025 | Medtronic Perfusion Systems DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12110 LV VENT 10FR, Model Number 12110 Open, Classified |
DWF | None listed |
| Sep 3, 2025 | Medtronic Perfusion Systems DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12115 LV VENT 15FR, Model Number 12115 Open, Classified |
DWF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.