AORTIC ROOT CANNULA W/INTEGRAL PRESS— 510(k) K831591
Substantially EquivalentDlp, Inc.
FDA 510(k) clearance K831591 for AORTIC ROOT CANNULA W/INTEGRAL PRESS, Substantially Equivalent on 1983-06-30. 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
- Mchenry, IL, 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 K831591
K-number listed on FDA's recall record- Z-2766-2017 — DLP Cardioplegia Adapter with Pressure Port Provides access for a pressure monitoring needle near the connection to the cardioplegia cannula. These adapters are intended for use in conjunction with the delivery of cardioplegia solution and to provide access for pressure monitoring for up to six hours
- Z-2767-2017 — DLP Pressure Monitoring Extension Line Adapters Extends the pressure line in order to reach the pressure monitoring unit during cardiopulmonary bypass surgery.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K831591.
Data sourced from openFDA. This site is unofficial and independent of the FDA.