Porous Media DPB30 Series Disposable Pre-Bypass Filter
FDA 510(k) K990276 · Porous Media Corp.
510(k) numberK990276
Submission
- Device name
- Porous Media DPB30 Series Disposable Pre-Bypass Filter
- Applicant
- Porous Media Corp.
St. Paul, MN, US - Received
- January 28, 1999
- Decision date
- October 1, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
|---|---|---|---|
| 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 |
| K861226 | Interface Crystalloid Cardioplegic Filter Model 70KRJ · Traditional | Medical, Inc. | 06/02/1986SE |
More from Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K062091 | Porous Media Humidiflow Humidifier for Universal HumidificationBTT · Traditional | 08/08/2006SE |
| K061426 | Oxygen Concentrator Filters, Models DBF32, DBF24, DBF27, DBF25, DFC06 and DDF47CAH · Traditional | 06/05/2006SE |
| K982385 | Porous Media DPB20 Series Disposable Pre-Bypass FilterKRJ · Traditional | 02/01/1999SE |
| K982127 | Porous Media DEF25 Disposable Respiratory FilterCAH · Special | 06/23/1998SE |
| K965020 | Porous Media DBF23 Reusable Respiratory FilterCAH · Traditional | 03/14/1997SE |
| K964979 | Porous Media DBF23 Disposable Respiratory FilterCAH · Traditional | 03/11/1997SE |
| K952428 | Porous Media DBF23-R Reusable Respiratory FilterCAH · Traditional | 07/07/1995SE |
| K934132 | Porous Media DBF23 Disposable Respiratory FilterCAH · Traditional | 10/04/1994SE |
Questions and answers
When was Porous Media DPB30 Series Disposable Pre-Bypass Filter cleared by the FDA?
Porous Media DPB30 Series Disposable Pre-Bypass Filter (K990276) received a 510(k) decision of Substantially Equivalent on October 1, 1999, 246 days after the submission was received.
What is the product code of K990276?
The FDA product code is KRJ – Filter, Prebypass, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4280.