SARNS 9000 HEART-LUNG CONSOLE— 510(k) K871131
Substantially Equivalent3M Health Care, Sarns
FDA 510(k) clearance K871131 for SARNS 9000 HEART-LUNG CONSOLE, Substantially Equivalent on 1987-05-21. Applicant: 3M Health Care, Sarns. Device class: 2.
Clearance details
- Applicant
- 3M Health Care, Sarns
- Product code
- Code DTQ
- Device class
- Class 2
- Regulation
- 21 CFR 870.4220
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Ann Arbor, MI, US
Recent devices under product code DTQ
view allMore clearances from 3M Health Care, Sarns
view allAdverse events under product code DTQ
product code DTQ- Death
- 123
- Malfunction
- 4,822
- Other
- 1
- Total
- 4,946
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 K871131
K-number listed on FDA's recall record- Z-2050-2012 — Sarns Modular Perfusion System 9000, 115V with color screen. The Sarns Perfusion System 9000 is indicated for use as a heart-lung system for pumping blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified perfusionist who is experienced in the operation of Sarns or similar equipment.
- Z-2051-2012 — Sarns Modular Perfusion System 9000, 220/240V with color screen. The Sarns Perfusion System 9000 is indicated for use as a heart-lung system for pumping blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified perfusionist who is experienced in the operation of Sarns or similar equipment.
- Z-2052-2012 — Sarns Modular Perfusion System 9000, 100V with color screen. The Sarns Perfusion System 9000 is indicated for use as a heart-lung system for pumping blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified perfusionist who is experienced in the operation of Sarns or similar equipment.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K871131.
Data sourced from openFDA. This site is unofficial and independent of the FDA.