Intersept*Prebypass Filter
FDA 510(k) K883086 · Medtronic Blood Systems, Inc.
510(k) numberK883086
Submission
- Device name
- Intersept*Prebypass Filter
- Applicant
- Medtronic Blood Systems, Inc.
Anaheim, CA, US - Received
- July 21, 1988
- Decision date
- September 16, 1988
- 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 |
| 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 |
| K861226 | Interface Crystalloid Cardioplegic Filter Model 70KRJ · Traditional | Medical, Inc. | 06/02/1986SE |
More from Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K944966 | Unipolar Atrial Temporary Pacing Lead,Model 6492LDF · Traditional | 07/14/1995SE |
| K944957 | Temporary Myocardial Pacing Lead, Model 6500LDF · Traditional | 07/14/1995SE |
| K893207 | Closed Chest Support CircuitDTZ · Traditional | 12/12/1989SE |
| K893678 | Duran Flexible Annuloplasty Ring & Obturator H601HKRH · Traditional | 11/27/1989SE |
| K891687 | Extracorporeal Circuit with Bio-Active SurfaceDTZ · Traditional | 05/31/1989SE |
| K891230 | Maxima* Hollow Fiber Oxygenator W/Filtered Reserv.DTZ · Traditional | 05/19/1989SE |
| K885154 | Intersept* Crystalloid Cardioplegia Deliv. SystemKRJ · Traditional | 02/22/1989SE |
| K884390 | Intersept* Crystalloid Cardioplegia FilterKRJ · Traditional | 12/21/1988SE |
| K884244 | Intersept* Prebypass FilterKRJ · Traditional | 12/05/1988SE |
| K883439 | Intersept*Crystalloid Cardioplegia Delivery SystemDTR · Traditional | 10/13/1988SE |
Questions and answers
When was Intersept*Prebypass Filter cleared by the FDA?
Intersept*Prebypass Filter (K883086) received a 510(k) decision of Substantially Equivalent on September 16, 1988, 57 days after the submission was received.
What is the product code of K883086?
The FDA product code is KRJ – Filter, Prebypass, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4280.