FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GAS FILTER
K Number: K993060
·
Decision Mar 28, 2000
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
11
Applicant Total
4
Review Days
197
Basic Information
- Device Name
- GAS FILTER
- K Number
- K993060
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4270
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- OLSON MEDICAL SALES, INC.
- Date Received
- September 13, 1999
- Decision Date
- March 28, 2000
- Product Code
- JOD
- 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 |
|---|---|---|---|
| JOD | Filter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JOD), ordered by most recent decision date.
CARDIOTOMY/AUTOTRANSFUSION/PLEURAL DRAINAGE VENOUS
FDA 510(k)
FDA Class 2
·Cardiovascular
PALL CARDIOPLEGIA PLUS FILTER W/POSIDYNE MEMBRANE
FDA 510(k)
FDA Class 2
·Cardiovascular
PALL STAT PRIME(TM) BLOOD FILTER FOR EXTRA. USE
FDA 510(k)
FDA Class 2
·Cardiovascular
SWANK CARDIOTOMY SUCTION LINE BLOOD FILTER CA100
FDA 510(k)
FDA Class 2
·Cardiovascular
CARDIO METRICS CARDIOTOMY RESERVOIR
FDA 510(k)
FDA Class 2
·Cardiovascular
CARDIOTOMY FILTER
FDA 510(k)
FDA Class 2
·Cardiovascular