ULTRAFLEX VENOUS CANNULA, MODEL 970XX AND CB970XX— 510(k) K031827
Substantially EquivalentMedtronic Perfusion Systems
FDA 510(k) clearance K031827 for ULTRAFLEX VENOUS CANNULA, MODEL 970XX AND CB970XX, Substantially Equivalent on 2003-07-02. Applicant: Medtronic Perfusion Systems. Device class: 2.
Clearance details
- Applicant
- Medtronic Perfusion Systems
- 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
- Special
- Location
- Minneapolis, MN, US
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- K090869 — MIRCSP (MINIMALLY INVASIVE RETROGRADE CORONARY SINUS PERFUSION) MANUAL INFLATE CANNULA, MODEL 94113TD
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.