FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CARDIO METRICS CARDIOTOMY RESERVOIR
K Number: K841958
·
Decision Oct 15, 1984
Classifications
1
FEI Numbers
7
Registration Numbers
7
Same Product Code
11
Applicant Total
10
Review Days
154
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
- CARDIO METRICS CARDIOTOMY RESERVOIR
- K Number
- K841958
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4270
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Sterile Design, Inc.
- Date Received
- May 14, 1984
- Decision Date
- October 15, 1984
- 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.
GAS FILTER
FDA 510(k)
FDA Class 2
·Cardiovascular
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
CARDIOTOMY FILTER
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Sterile Design, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K934688 | STERILE DESIGN | Mar 16, 1994 | Unknown |
| K841960 | CARDIO METRICS INVASIVE PRESSURE MONIT | Nov 8, 1985 | Substantially Equivalent |
| K842356 | CUSTOM STERILE PROCEDURE KITS | Mar 21, 1985 | Substantially Equivalent |
| K841959 | CARDIO METRIC CUSTOM PERFUSION TUBING | Oct 19, 1984 | Substantially Equivalent |
| K842351 | STERILE DESIGN-CUSTOM STERILE IV KIT | Oct 15, 1984 | Substantially Equivalent |
| K834239 | SDI C-FLEX STERILE LIGHT HANDLE | Apr 25, 1984 | Substantially Equivalent |
| K834237 | GRADUATED GUIDE WIRE BOWL 8 | Feb 4, 1984 | Substantially Equivalent |
| K813437 | PAN SET | Dec 31, 1981 | Substantially Equivalent |
| K791738 | CUSTOM DRESSING CHANGE TRAYS | Oct 2, 1979 | Substantially Equivalent |