3-WAY Stopcock with Luer-Lock Fitting
FDA 510(k) K770154 · American Viggo
510(k) numberK770154
Submission
- Device name
- 3-WAY Stopcock with Luer-Lock Fitting
- Applicant
- American Viggo
Mchenry, IL, US - Received
- January 24, 1977
- Decision date
- February 28, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KGZ – Accessories, Catheter
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4200
- Specialty
- General, Plastic Surgery
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| K022306 | Aart Silicone TubingKGZ · Traditional | Aesthetic and Reconstructive Technologies, Inc. | 10/10/2002SE |
| K974295 | Byron Medical Aspiration and Infiltration/Irrigation TubingKGZ · Traditional | Byron Medical | 02/10/1998SE |
| K973183 | Wound Drainage HolderKGZ · Traditional | R & D Medical Products, Inc. | 01/23/1998SE |
| K955433 | Duralastic Silicone TubingKGZ · Traditional | Allied Biomedical Corp. | 01/26/1996SE |
| K942315 | Navarre Percutaneous Access SetKGZ · Traditional | Navarre Biomedical , Ltd. | 07/08/1994SE |
| K896087 | Palestrant Irrigation and Drainage SetKGZ · Traditional | North American Instrument Corp. | 11/03/1989SE |
| K895041 | Optical Catheter(Tm) Introducer SetsKGZ · Traditional | Medical Dynamics, Inc. | 10/16/1989SE |
| K893406 | Deseret PRN AdapterKGZ · Traditional | Deseret Medical, Inc. | 06/22/1989SE |
| K873009 | Concept Switching StickKGZ · Traditional | Concept, Inc. | 08/17/1987SE |
| K870014 | Hci General Purpose Catheter StyletKGZ · Traditional | Health Care Innovations, Inc. | 02/06/1987SE |
More from Health Care Innovations, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K771339 | Male Luer Lock PlugFPA · Traditional | 08/02/1977SE |
| K770528 | Needle, MembraneFMI · Traditional | 04/29/1977SE |
| K770181 | I.V. Catheter Placement UnitFOZ · Traditional | 03/30/1977SE |
| K770174 | Luer-Lock Extension SetFPK · Traditional | 03/30/1977SE |
| K770096 | Epidural Block Procedure PackCAZ · Traditional | 02/25/1977SE |
| K760679 | 4-WAY Stopcock W/7CM Tubing,FMG · Traditional | 12/02/1976SE |
| K760678 | 4-WAY Stopcock W/100 CM Tubing, Luer-LkFMG · Traditional | 12/02/1976SE |
| K760667 | 4-WAY Stopcock W/10 CM Exten. TubingFMG · Traditional | 12/02/1976SE |
| K760666 | 4-WAY Stopcock W/Luer-Lock FittingFMG · Traditional | 12/02/1976SE |
Questions and answers
When was 3-WAY Stopcock with Luer-Lock Fitting cleared by the FDA?
3-WAY Stopcock with Luer-Lock Fitting (K770154) received a 510(k) decision of Substantially Equivalent on February 28, 1977, 35 days after the submission was received.
What is the product code of K770154?
The FDA product code is KGZ – Accessories, Catheter, a Class I (low risk) device regulated under 21 CFR 878.4200.