Interface Cardiotomy Blood Filter
FDA 510(k) K781383 · Medical, Inc.
510(k) numberK781383
Submission
- Device name
- Interface Cardiotomy Blood Filter
- Applicant
- Medical, Inc.
Mchenry, IL, US - Received
- August 11, 1978
- Decision date
- September 27, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JOD – Filter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4270
- Specialty
- Cardiovascular
Other 510(k)s with product code JOD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K993060 | Gas FilterJOD · Traditional | Olson Medical Sales, Inc. | 03/28/2000SE |
| K890504 | Cardiotomy/Autotransfusion/Pleural Drainage VenousJOD · Traditional | Gish Biomedical, Inc. | 03/10/1989SE |
| K875095 | Pall Cardioplegia Plus Filter W/Posidyne MembraneJOD · Traditional | Pall Biomedical Products Co. | 02/29/1988SE |
| K874405 | Pall Stat Prime(Tm) Blood Filter for Extra. UseJOD · Traditional | Pall Biomedical Products Co. | 12/30/1987SE |
| K855067 | Swank Cardiotomy Suction Line Blood Filter CA100JOD · Traditional | Cobe Laboratories, Inc. | 02/26/1986SE |
| K841958 | Cardio Metrics Cardiotomy ReservoirJOD · Traditional | Sterile Design, Inc. | 10/15/1984SE |
| K830634 | Cardiotomy FilterJOD · Traditional | Texas Medical Products, Inc. | 06/30/1983SE |
| K823260 | Interface Cardiotomy Blood Filter #51JOD · Traditional | Medical, Inc. | 11/24/1982SE |
| K823259 | Interface Cardiotomy Blood Filter #50JOD · Traditional | Medical, Inc. | 11/24/1982SE |
| K812243 | Interface Cardiotomy Blood Filter #51JOD · Traditional | Medical, Inc. | 08/25/1981SE |
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| K872001 | Model TPC-1A Oxygen AnalyzerCCL · Traditional | 06/15/1987SE |
| K863806 | Model A-1 Oxygen AnalyzerCCL · Traditional | 10/15/1986SE |
| K862609 | Interface Arterial Blood Filter, Model 44DTM · Traditional | 09/04/1986SE |
| K862591 | Interface Arterial Blood Filter, Model 42DTM · Traditional | 09/04/1986SE |
| K861226 | Interface Crystalloid Cardioplegic Filter Model 70KRJ · Traditional | 06/02/1986SE |
| K851370 | Interface Transfusion Blood Filter #35CAK · Traditional | 06/27/1985SE |
| K823261 | Interface Transfusion Blood Filter #30CAK · Traditional | 01/07/1983SE |
Questions and answers
When was Interface Cardiotomy Blood Filter cleared by the FDA?
Interface Cardiotomy Blood Filter (K781383) received a 510(k) decision of Substantially Equivalent on September 27, 1978, 47 days after the submission was received.
What is the product code of K781383?
The FDA product code is JOD – Filter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4270.