Deseret PRN Adapter
FDA 510(k) K893406 · Deseret Medical, Inc.
510(k) numberK893406
Submission
- Device name
- Deseret PRN Adapter
- Applicant
- Deseret Medical, Inc.
Sandy, UT, US - Received
- May 2, 1989
- Decision date
- June 22, 1989
- 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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| 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 |
| K873009 | Concept Switching StickKGZ · Traditional | Concept, Inc. | 08/17/1987SE |
| K870014 | Hci General Purpose Catheter StyletKGZ · Traditional | Health Care Innovations, Inc. | 02/06/1987SE |
| K864115 | Tubegripper, Drainage Catheter & Accessory for SuKGZ · Traditional | Cathaid, Inc. | 11/07/1986SE |
More from Cathaid, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K913027 | Vessel DilatorDRE · Traditional | 11/27/1991SE |
| K904648 | Safe Syte I.V. Catheter Placement UnitFOZ · Traditional | 12/14/1990SE |
| K904121 | Vialon ObturatorFOZ · Traditional | 11/08/1990SE |
| K904122 | Insyte-A Arterial Catheterization UnitFOZ · Traditional | 10/04/1990SE |
| K900116 | Deseret Optima Intravascular CatheterFOZ · Traditional | 06/18/1990SE |
| K895735 | Deseret Multilumen Subclavian CatheterLYY · Traditional | 05/18/1990SE |
| K895734 | Deseret Intravascular CatheterFOZ · Traditional | 04/09/1990SE |
| K894033 | Disposable Catheter Pressure TransducerDXO · Traditional | 10/17/1989SE |
| K882798 | Multiflo AdapterFPA · Traditional | 07/18/1988SE |
| K882797 | Luer-Lok Multiflo AdapterFPA · Traditional | 07/18/1988SE |
Questions and answers
When was Deseret PRN Adapter cleared by the FDA?
Deseret PRN Adapter (K893406) received a 510(k) decision of Substantially Equivalent on June 22, 1989, 51 days after the submission was received.
What is the product code of K893406?
The FDA product code is KGZ – Accessories, Catheter, a Class I (low risk) device regulated under 21 CFR 878.4200.