Coil Dialyzer Model Alt 140
FDA 510(k) K761358 · Bentley Laboratories, Inc.
510(k) numberK761358
Submission
- Device name
- Coil Dialyzer Model Alt 140
- Applicant
- Bentley Laboratories, Inc.
Mchenry, IL, US - Received
- December 29, 1976
- Decision date
- January 10, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FHS – Dialyzer, Single Coil
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5820
- Specialty
- Gastroenterology, Urology
- Life-sustaining
- Yes
Other 510(k)s with product code FHS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K812811 | Microcoil 80 DialyzerFHS · Traditional | Erika, Inc. | 12/03/1981SE |
| K811974 | Microcoil 150 DialyzerFHS · Traditional | Erika, Inc. | 09/16/1981SE |
| K801634 | The Vita 2 Disposable DialyzerFHS · Traditional | Bellco Artifidial Organ Spec., Inc. | 12/17/1980SE |
| K800723 | Micro-Coil 100 Coil DialyzerFHS · Traditional | Erika, Inc. | 05/14/1980SE |
| K800174 | Gambro Lundia Coil DialyzerFHS · Traditional | Gambro, Inc. | 02/13/1980SE |
| K790223 | Dialyzer, CD-800 CoilFHS · Traditional | Travenol Laboratories, S.A. | 03/26/1979SE |
| K781102 | Dialyzer, Disp., Coil, LundiaFHS · Traditional | Gambro, Inc. | 10/17/1978SE |
| K771349 | Modification to Kidney DialyzerFHS · Traditional | Erika, Inc. | 08/02/1977SE |
| K770735 | Dialyzer, Coil, CD, Lsa, 5M1765FHS · Traditional | Travenol Laboratories, S.A. | 05/10/1977SE |
| K760702 | Eri-Flo 900 DialyzerFHS · Traditional | Erika, Inc. | 11/19/1976SE |
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| K903641 | Quick Prime Hemoconcen. No. HQ-7000 and CBP-7000QKDI · Traditional | 11/09/1990SE |
| K894826 | Univox W/Holders, Models Univox-Hl, HLB, HLFDTZ · Traditional | 02/28/1990SE |
| K874867 | Catr(Tm)-H Cardiotomy HolderKPI · Traditional | 02/02/1988SE |
| K874841 | Integrated Membrane Oxygenator W/Cardiotomy FilterDTZ · Traditional | 02/02/1988SE |
| K874618 | Baxter Accuport(Tm) Central Venous CatheterDQR · Traditional | 01/19/1988SE |
| K823359 | Oxygen Consumption Monitor #OCM-0100DRY · Traditional | 01/05/1983SE |
| K823273 | BOS-2S, Spiraflo Bubble Infant Oxygen.DTZ · Traditional | 01/05/1983SE |
Questions and answers
When was Coil Dialyzer Model Alt 140 cleared by the FDA?
Coil Dialyzer Model Alt 140 (K761358) received a 510(k) decision of Substantially Equivalent on January 10, 1977, 12 days after the submission was received.
What is the product code of K761358?
The FDA product code is FHS – Dialyzer, Single Coil, a Class II (moderate risk) device regulated under 21 CFR 876.5820.