MEDTRONIC DLP ARTERIAL CANNULAE WITH 3D TIP— 510(k) K000776
Substantially EquivalentMedtronic Cardiac Surgical Products
FDA 510(k) clearance K000776 for MEDTRONIC DLP ARTERIAL CANNULAE WITH 3D TIP, Substantially Equivalent on 2001-02-07. Applicant: Medtronic Cardiac Surgical Products. Device class: 2.
Clearance details
- Applicant
- Medtronic Cardiac Surgical Products
- 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 Medtronic Cardiac Surgical Products
view all- K022272 — MALLEABLE SINGLE STAGE VENOUS CANNULA, MODELS 68112-68140 (15 TOTAL CODES)
- K013013 — MEDTRONIC DLP ARTERIAL CANNULA WITH 3D TIP - 22 FR.
- K012143 — 24 FR. LEFT HEART VENT CATHETER WITH PRESSURE MONITORING LINE, MODEL 12524
- K010737 — SELECT CAP ARTERIAL CANNULA WITH PRESSURE MONITORING LINE, MODEL 78818,78820,78822,78824,78918,78920,78922,78924
- K994171 — MEDTRONIC AORTOCORONARY SHUNT AND SEPARATELY PACKAGED ARTERIOTOMY CANNULAE
Adverse 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 K000776
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K000776.
Data sourced from openFDA. This site is unofficial and independent of the FDA.