Duo Flow Catheter-Mc 54
FDA 510(k) K842416 · Medical Components, Inc.
510(k) numberK842416
Submission
- Device name
- Duo Flow Catheter-Mc 54
- Applicant
- Medical Components, Inc.
Mchenry, IL, US - Received
- June 20, 1984
- Decision date
- July 26, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KNZ – Accessories, A-V Shunt
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5540
- Specialty
- Gastroenterology, Urology
- Implant
- Yes
Other 510(k)s with product code KNZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K842039 | Argon Dual Lumen Hemodialysis, CatheterKNZ · Traditional | Argon Medical Corp. | 01/29/1985SE |
| K844612 | Acute Hemodialysis TraysKNZ · Traditional | Packaging Technologies, Inc. | 12/17/1984SE |
| K842864 | Vaccess Femoral CannulaKNZ · Traditional | Vas-Cath of Canada , Ltd. | 08/08/1984SE |
| K841530 | Double Lumen Sublcavian-FemoralKNZ · Traditional | Medical Components, Inc. | 06/25/1984SE |
| K841119 | Tops Dispos. Infusion Set/HemodialysisKNZ · Traditional | Top Surgical Manufacturers Co. | 04/20/1984SE |
| K840424 | Hemocath Repair KitKNZ · Traditional | Quinton, Inc. | 03/05/1984SE |
| K840437 | Hemasite Accessories ModificationKNZ · Traditional | Renal Systems, Inc. | 02/21/1984SE |
| K834510 | Renaflo Avf Set for HemodialysisKNZ · Traditional | Renal Systems, Inc. | 02/04/1984SE |
| K833139 | Acute Hemodialysis TraysKNZ · Traditional | Intermed, Inc. | 12/22/1983SE |
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| K124046 | Valved Tearaway Introducer Generation IIDYB · Traditional | 06/03/2013SE |
| K123617 | 3F Pro-PiccLJS · Traditional | 05/15/2013SE |
| K122423 | Vasu-PiccLJS · Traditional | 12/12/2012SE |
| K121848 | Split Cath III 24CM Split Cath III 24CM Split Cath III 32CM Cath III 36CM Split Cath III…MSD · Special | 09/21/2012SESK |
Questions and answers
When was Duo Flow Catheter-Mc 54 cleared by the FDA?
Duo Flow Catheter-Mc 54 (K842416) received a 510(k) decision of Substantially Equivalent on July 26, 1984, 36 days after the submission was received.
What is the product code of K842416?
The FDA product code is KNZ – Accessories, A-V Shunt, a Class II (moderate risk) device regulated under 21 CFR 876.5540.