INFANT VENT CATHETER 12001 W/SIDE VENT— 510(k) K834039
Substantially EquivalentDlp, Inc.
FDA 510(k) clearance K834039 for INFANT VENT CATHETER 12001 W/SIDE VENT, Substantially Equivalent on 1984-01-03. Applicant: Dlp, Inc.. Device class: 2.
Clearance details
- Applicant
- Dlp, Inc.
- Product code
- Code DWF
- Device class
- Class 2
- Regulation
- 21 CFR 870.4210
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Grand Rapids, MI, US
Recent devices under product code DWF
view allMore clearances from Dlp, Inc.
view allAdverse events under product code DWF
product code DWF- Death
- 106
- Injury
- 386
- Malfunction
- 2,323
- Total
- 2,815
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K834039
K-number listed on FDA's recall record- Z-2480-2025 — DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12113 LV VENT 13FR, Model Number 12113
- Z-2481-2025 — DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12110 LV VENT 10FR, Model Number 12110
- Z-2482-2025 — DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12115 LV VENT 15FR, Model Number 12115
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K834039.
Data sourced from openFDA. This site is unofficial and independent of the FDA.