Shiley Prebypass Filter
FDA 510(k) K840450 · Shiley, Inc.
510(k) numberK840450
Submission
- Device name
- Shiley Prebypass Filter
- Applicant
- Shiley, Inc.
Mchenry, IL, US - Received
- February 1, 1984
- Decision date
- April 17, 1984
- 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 |
More from American Omni Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K920594 | Shiley Perfusion Tubing SetsDTM · Traditional | 03/18/1993SE |
| K910991 | Shiley Therapeutic Autotransfusion SystemCAC · Traditional | 11/27/1991SE |
| K911876 | Shiley Plexus(R) Venous Reservoir, PVR1200DTN · Traditional | 08/09/1991SE |
| K910923 | BCD AdvancedDTR · Traditional | 04/09/1991SE |
| K901548 | Biomedical Sensors-Shiley BGM 4000 Intra Blood GasCCC · Traditional | 01/14/1991SE |
| K903435 | Shiley Specialized Tracheostomy TubeJOH · Traditional | 10/02/1990SE |
| K901624 | Shiley Plexus Integral Reservoir Hollow Fiber Oxy.DTZ · Traditional | 07/03/1990SE |
| K901250 | Plexus 2(TM) Infant Hollow Fiber OxygenatorDTZ · Traditional | 06/11/1990SE |
| K901249 | Plexus 3.5(TM) Pediatric Hollow Fiber OxygenatorDTZ · Traditional | 06/11/1990SE |
| K900797 | Stockert Shiley Dual Pressure Control Module XRDXS · Traditional | 05/10/1990SE |
Questions and answers
When was Shiley Prebypass Filter cleared by the FDA?
Shiley Prebypass Filter (K840450) received a 510(k) decision of Substantially Equivalent on April 17, 1984, 76 days after the submission was received.
What is the product code of K840450?
The FDA product code is KRJ – Filter, Prebypass, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4280.