RETROGRADE CORONARY SINUS PERFUSION CANNULA WITH NO PRESSURE LINE (15 FRENCH, MANUAL AND AUTO INFLATE)— 510(k) K030696
Substantially EquivalentMedtronic Perfusion Systems
FDA 510(k) clearance K030696 for RETROGRADE CORONARY SINUS PERFUSION CANNULA WITH NO PRESSURE LINE (15 FRENCH, MANUAL AND AUTO INFLATE), Substantially Equivalent on 2003-04-11. 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
- Brooklyn Park, MN, US
Recent devices under product code DWF
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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.