Deseret Subclavian Hemodialysis Catheter
FDA 510(k) K881695 · Deseret Medical, Inc.
510(k) numberK881695
Submission
- Device name
- Deseret Subclavian Hemodialysis Catheter
- Applicant
- Deseret Medical, Inc.
Sandy, UT, US - Received
- April 19, 1988
- Decision date
- June 23, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LFJ – Catheter, Subclavian
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5540
- Specialty
- Gastroenterology, Urology
- Implant
- Yes
Other 510(k)s with product code LFJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K920780 | Medsurg Insertion TrayLFJ · Traditional | Medsurg Industries, Inc. | 08/19/1994SEKD |
| K925819 | AKCESS0CATH KitLFJ · Traditional | Akcess Medical Products, Inc. | 08/02/1994SE |
| K925818 | Akcess-CathLFJ · Traditional | Akcess Medical Products, Inc. | 04/05/1994SE |
| K913468 | Uldall Double Lumen Hemodialysis Catheter Set/TrayLFJ · Traditional | Cook, Inc. | 03/24/1994SE |
| K931120 | Coaxial Acute CatheterLFJ · Traditional | Akcess Medical Products, Inc. | 01/14/1994SE |
| K920634 | Splittable Sheath Introducer SetLFJ · Traditional | Akcess Medical Products, Inc. | 01/14/1994SE |
| K914162 | Vas-Cath Flexxicon 2 Dual Lumen Dialysis CathetersLFJ · Traditional | Vas-Cath, Inc. | 07/01/1993SE |
| K915423 | Hemo-Cath Silicone Access CatheterLFJ · Traditional | Medical Components, Inc. | 02/02/1993SESK |
| K914826 | Akcess-Cath KitLFJ · Traditional | Akcess Medical Products, Inc. | 04/10/1992SESK |
| K910501 | Permanent Silicone CathetersLFJ · Traditional | Akcess Medical Products, Inc. | 04/29/1991SE |
More from Akcess Medical Products, 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 |
| K893406 | Deseret PRN AdapterKGZ · Traditional | 06/22/1989SE |
| K882798 | Multiflo AdapterFPA · Traditional | 07/18/1988SE |
Questions and answers
When was Deseret Subclavian Hemodialysis Catheter cleared by the FDA?
Deseret Subclavian Hemodialysis Catheter (K881695) received a 510(k) decision of Substantially Equivalent on June 23, 1988, 65 days after the submission was received.
What is the product code of K881695?
The FDA product code is LFJ – Catheter, Subclavian, a Class II (moderate risk) device regulated under 21 CFR 876.5540.