ROTAFLOW CENTRIFUGAL PUMP SYSTEM— 510(k) K991864
Substantially EquivalentJostra Medizintechnik AG
FDA 510(k) clearance K991864 for ROTAFLOW CENTRIFUGAL PUMP SYSTEM, Substantially Equivalent on 2000-08-31. Applicant: Jostra Medizintechnik AG. Device class: 2.
Clearance details
- Applicant
- Jostra Medizintechnik AG
- Product code
- Code KFM
- Device class
- Class 2
- Regulation
- 21 CFR 870.4360
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Newark, DE, US
Recent devices under product code KFM
view all- K251762 — Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors (CP20V-NG)
- K250326 — Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors (CP22V-NG)
- K233091 — Quantum Perfusion Centrifugal Blood Pump CP37 with Integrated Sensors (CP37V-VT) +1 more
- K232132 — LifeSPARC System
- K220842 — Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors, Quantum Perfusion Centrifugal Blood Pump CP20 with Integrated Sensors
More clearances from Jostra Medizintechnik AG
view allAdverse events under product code KFM
product code KFM- Death
- 109
- Injury
- 241
- Malfunction
- 1,779
- Total
- 2,129
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 K991864
K-number listed on FDA's recall record- Z-2957-2020 — Maquet/Getinge Rotaflow System Console US (115 V / 60 Hz) - Product Usage: Instructions for Use - Centrifugal Pump System is a device that uses a method other than revolving rollers to pump the blood through an extracorporeal circuit Material Number: 701043292
- Z-0678-2020 — Maquet Cardiopulmonary (MCP)/Getinge ROTAFLOW Drive, Model Number 701022161. The device is a component of the ROTAFLOW System Console.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K991864.
Data sourced from openFDA. This site is unofficial and independent of the FDA.