Hurwitz Dialysis Catheter
FDA 510(k) K860094 · Gish Biomedical, Inc.
510(k) numberK860094
Submission
- Device name
- Hurwitz Dialysis Catheter
- Applicant
- Gish Biomedical, Inc.
Santa Ana, CA, US - Received
- January 10, 1986
- Decision date
- April 7, 1986
- 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.
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|---|---|---|
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| K091062 | Medos Hilite Infant Reservoir, Model MVC 0730DTN · Traditional | 08/04/2009SE |
| K083131 | Medos Hilite Reservoir, Model: 4030DTN · Traditional | 07/30/2009SE |
| K082403 | Medos Hilite Oxygenator, Model 7000 & 7000 LTDTZ · Traditional | 05/15/2009SE |
| K082082 | Gish SVR Soft Venous Reservoirs with Ha CoatingDTN · Traditional | 02/04/2009SE |
| K081947 | Gish CAPVRF44 Hardshell Venous Reservoir with Ha CoatingDTN · Traditional | 02/04/2009SE |
| K080708 | Vision Hollow Fiber Oxygenator with Ha CoatingDTZ · Traditional | 02/02/2009SE |
| K081838 | Gish Vision Blood Cardioplegia with Ha CoatingDTR · Traditional | 01/26/2009SE |
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Questions and answers
When was Hurwitz Dialysis Catheter cleared by the FDA?
Hurwitz Dialysis Catheter (K860094) received a 510(k) decision of Substantially Equivalent on April 7, 1986, 87 days after the submission was received.
What is the product code of K860094?
The FDA product code is LFJ – Catheter, Subclavian, a Class II (moderate risk) device regulated under 21 CFR 876.5540.