3M SARNS FLOW SENSOR, CENTRIFUGAL CONTROL MODULE 115, 220 V, 900 PERFUSION SYSTEM— 510(k) K950739
Substantially Equivalent3M Health Care, Sarns
FDA 510(k) clearance K950739 for 3M SARNS FLOW SENSOR, CENTRIFUGAL CONTROL MODULE 115, 220 V, 900 PERFUSION SYSTEM, Substantially Equivalent on 1995-11-17. Applicant: 3M Health Care, Sarns. Device class: 2.
Clearance details
- Applicant
- 3M Health Care, Sarns
- Product code
- Code DWA
- Device class
- Class 2
- Regulation
- 21 CFR 870.4380
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Ann Arbor, MI, US
Recent devices under product code DWA
view all- K232788 — INSPIRA ART100
- K230698 — Anivia SG1000 Pump Console
- K221491 — Anivia SG1000 Pump Console
- K192838 — Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium Pressure
- K200306 — CentriMag Circulatory Support System, CentriMag Return (Arterial) Cannula Kit, CentriMag Drainage (Venous) Cannula Kit
More clearances from 3M Health Care, Sarns
view allAdverse events under product code DWA
product code DWA- Death
- 15
- Malfunction
- 1,654
- Total
- 1,669
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.