FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
JOSTRA HL-15 MODULAR HEART-LUNG MACHINE (HEREINAFTER CALLED THE HL-15 OR THE DEVICE
K Number: K945720
·
Decision Mar 29, 1995
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
29
Applicant Total
3
Review Days
128
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- JOSTRA HL-15 MODULAR HEART-LUNG MACHINE (HEREINAFTER CALLED THE HL-15 OR THE DEVICE
- K Number
- K945720
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Jostra Bentley
- Date Received
- November 21, 1994
- Decision Date
- March 29, 1995
- Product Code
- DWC
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DWC | Controller, Temperature, Cardiopulmonary Bypass | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DWC), ordered by most recent decision date.
Heater-Cooler System 3T
FDA 510(k)
FDA Class 2
·Cardiovascular
Quantum Heater-Cooler
FDA 510(k)
FDA Class 2
·Cardiovascular
Heater-Cooler System 3T
FDA 510(k)
FDA Class 2
·Cardiovascular
SORIN FLEXTHERM
FDA 510(k)
FDA Class 2
·Cardiovascular
HEATER-COOLER UNIT HCU 40
FDA 510(k)
FDA Class 2
·Cardiovascular
HEMOTHERM MODEL 400CE COOLER/HEATER SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular