CARDIOPULMONARY BYPASS— 510(k) K810820
Substantially EquivalentDlp, Inc.
FDA 510(k) clearance K810820 for CARDIOPULMONARY BYPASS, Substantially Equivalent on 1981-04-03. 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
- Walker, 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 K810820
K-number listed on FDA's recall record- Z-1796-2024 — Medtronic I.M.A. Cannulae: DLP¿ 1 mm Arteriotomy Cannula, Model Number 31001
- Z-1799-2024 — Medtronic Vessel Cannulae: a) DLP¿ 2 mm Vessel Cannula Blunt Tip, Model Number 30004; b) DLP¿ 3 mm Vessel Cannula Blunt Tip, Model Number 30003
- Z-1316-2024 — Medtronic DLP Vessel Cannula, Model Number REF 30000
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K810820.
Data sourced from openFDA. This site is unofficial and independent of the FDA.