Genesis Low Temperature Reusable Rigid Container System— 510(k) K153554
Substantially EquivalentCarefusion 2200, Inc.
FDA 510(k) clearance K153554 for Genesis Low Temperature Reusable Rigid Container System, Substantially Equivalent on 2016-03-21. Applicant: Carefusion 2200, Inc.. Device class: 2.
Clearance details
- Applicant
- Carefusion 2200, Inc.
- Product code
- Code KCT
- Device class
- Class 2
- Regulation
- 21 CFR 880.6850
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Vernon Hills, IL, US
Recent devices under product code KCT
view allMore clearances from Carefusion 2200, Inc.
view all- K210324 — V. Mueller Cosgrove Flex Clamps, Model Number-CV1033, CV1061, CV1133, CV1161, CV1186
- K163615 — Snowden-Pencer MicroLap 3mm Laparoscopic Instruments
- K162432 — Multi-Link X2 ECG Cable and Lead Wire System
- K160764 — AirLife Autofill Humidification Chamber
- K151036 — Snowden-Pencer Ergonomic Take-Apart In-Line and Pistol Grip Laparoscopic Instruments
Data sourced from openFDA. This site is unofficial and independent of the FDA.