Dialyzer, Parallel Flow Disposable
FDA 510(k) K781795 · Medical, Inc.
510(k) numberK781795
Submission
- Device name
- Dialyzer, Parallel Flow Disposable
- Applicant
- Medical, Inc.
Mchenry, IL, US - Received
- October 25, 1978
- Decision date
- December 15, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FJG – Dialyzer, Parallel Flow
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5820
- Specialty
- Gastroenterology, Urology
- Life-sustaining
- Yes
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|---|---|---|---|
| K933681 | Gambro Lundia Pro 100, 500, 600 DialyzersFJG · Traditional | Cobe Renal Care, Inc. | 09/07/1994SE |
| K933680 | Gambro Lundia Pro 200 DialyzerFJG · Traditional | Cobe Renal Care, Inc. | 08/26/1994SE |
| K920693 | Dextrolyte II Peritoneal Dialysis 48-3028-9FJG · Traditional | National Medical Care, Medical Products Div., Inc. | 09/21/1992SE |
| K915504 | Gambro Lundia Alpha HemodialyzersFJG · Traditional | C.G.H. Medical, Inc. | 03/06/1992SE |
| K901368 | Hemospal Kits A1, A2D, Ao, & A1DFJG · Traditional | Gambro-Hospal, Inc. | 08/02/1990SE |
| K902203 | Tenckhoff Peritoneal Dialysis KitFJG · Traditional | Akcess Medical Products, Inc. | 08/01/1990SESK |
| K862840 | Gambro Lundia 10-1L, 1N, 1H, 3H, 4N, 4H, 5H, 6NFJG · Traditional | Gambro, Inc. | 09/29/1986SE |
| K853406 | Gambro Lundia Pro 3 & 5 DialyzerFJG · Traditional | Gambro, Inc. | 01/08/1986SE |
| K820694 | Cobe PPD 1.3L, #18-520-009FJG · Traditional | Cobe Laboratories, Inc. | 03/31/1982SE |
| K812336 | Cobe PPD 1.9FJG · Traditional | Cobe Laboratories, Inc. | 08/31/1981SE |
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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 Dialyzer, Parallel Flow Disposable cleared by the FDA?
Dialyzer, Parallel Flow Disposable (K781795) received a 510(k) decision of Substantially Equivalent on December 15, 1978, 51 days after the submission was received.
What is the product code of K781795?
The FDA product code is FJG – Dialyzer, Parallel Flow, a Class II (moderate risk) device regulated under 21 CFR 876.5820.