Dual Lumen Sub-Clavian Cath Kit, DLSC 600K & 800K
FDA 510(k) K891755 · Akcess Medical Products, Inc.
510(k) numberK891755
Submission
- Device name
- Dual Lumen Sub-Clavian Cath Kit, DLSC 600K & 800K
- Applicant
- Akcess Medical Products, Inc.
New Brunswick, NJ, US - Received
- March 23, 1989
- Decision date
- June 8, 1989
- 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 |
|---|---|---|
| K926374 | Silicone Catheter Repair KitsKOC · Traditional | 10/07/1994SESK |
| K925819 | AKCESS0CATH KitLFJ · Traditional | 08/02/1994SE |
| K925818 | Akcess-CathLFJ · Traditional | 04/05/1994SE |
| K930630 | Right Atrial CatheterLJS · Traditional | 02/07/1994SN |
| K931120 | Coaxial Acute CatheterLFJ · Traditional | 01/14/1994SE |
| K920634 | Splittable Sheath Introducer SetLFJ · Traditional | 01/14/1994SE |
| K914936 | Continuous Arteriovenous Hemofiltration Cath SetLFK · Traditional | 04/23/1992SESK |
| K920331 | Right Atrial Catheter KitsDQY · Traditional | 04/22/1992SESK |
| K914826 | Akcess-Cath KitLFJ · Traditional | 04/10/1992SESK |
| K915215 | Continuous Arteriovenous Hemofiltration Cath. KitsLFK · Traditional | 03/27/1992SESK |
Questions and answers
When was Dual Lumen Sub-Clavian Cath Kit, DLSC 600K & 800K cleared by the FDA?
Dual Lumen Sub-Clavian Cath Kit, DLSC 600K & 800K (K891755) received a 510(k) decision of Substantially Equivalent on June 8, 1989, 77 days after the submission was received.
What is the product code of K891755?
The FDA product code is LFJ – Catheter, Subclavian, a Class II (moderate risk) device regulated under 21 CFR 876.5540.