Interface Crystalloid Cardioplegic Filter Model 70
FDA 510(k) K861226 · Medical, Inc.
510(k) numberK861226
Submission
- Device name
- Interface Crystalloid Cardioplegic Filter Model 70
- Applicant
- Medical, Inc.
Inver Grove Heights, MN, US - Received
- April 1, 1986
- Decision date
- June 2, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KRJ – Filter, Prebypass, Cardiopulmonary Bypass
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4280
- Specialty
- Cardiovascular
Other 510(k)s with product code KRJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K990276 | Porous Media DPB30 Series Disposable Pre-Bypass FilterKRJ · Traditional | Porous Media Corp. | 10/01/1999SE |
| K982385 | Porous Media DPB20 Series Disposable Pre-Bypass FilterKRJ · Traditional | Porous Media Corp. | 02/01/1999SE |
| K940126 | Avecor Pre-Bypass FilterKRJ · Traditional | Avecor Cardiovascular, Inc. | 06/28/1994SE |
| K900672 | Prebypass Filter, Cat. No. FPB-5KRJ · Traditional | American Omni Medical, Inc. | 04/03/1990SE |
| K885154 | Intersept* Crystalloid Cardioplegia Deliv. SystemKRJ · Traditional | Medtronic Blood Systems, Inc. | 02/22/1989SE |
| K884390 | Intersept* Crystalloid Cardioplegia FilterKRJ · Traditional | Medtronic Blood Systems, Inc. | 12/21/1988SE |
| K884244 | Intersept* Prebypass FilterKRJ · Traditional | Medtronic Blood Systems, Inc. | 12/05/1988SE |
| K883086 | Intersept*Prebypass FilterKRJ · Traditional | Medtronic Blood Systems, Inc. | 09/16/1988SE |
| K875094 | Ultipor Pre-Bypass Plus Filter W/Posidyne MembraneKRJ · Traditional | Pall Biomedical Products Co. | 02/29/1988SE |
| K871350 | Prebypass FilterKRJ · Traditional | American Omni Medical, Inc. | 06/08/1987SE |
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| K894839 | OS-1 Occlusion System - 1BZC · Traditional | 10/24/1989SE |
| 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 |
| K851370 | Interface Transfusion Blood Filter #35CAK · Traditional | 06/27/1985SE |
| K823261 | Interface Transfusion Blood Filter #30CAK · Traditional | 01/07/1983SE |
| K823260 | Interface Cardiotomy Blood Filter #51JOD · Traditional | 11/24/1982SE |
Questions and answers
When was Interface Crystalloid Cardioplegic Filter Model 70 cleared by the FDA?
Interface Crystalloid Cardioplegic Filter Model 70 (K861226) received a 510(k) decision of Substantially Equivalent on June 2, 1986, 62 days after the submission was received.
What is the product code of K861226?
The FDA product code is KRJ – Filter, Prebypass, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4280.