Vaccess 3000 Single Lumen Jugular Cannula-Cath
FDA 510(k) K844434 · Vas-Cath of Canada , Ltd.
510(k) numberK844434
Submission
- Device name
- Vaccess 3000 Single Lumen Jugular Cannula-Cath
- Applicant
- Vas-Cath of Canada , Ltd.
Ontario, L5a 3v3, CA - Received
- November 16, 1984
- Decision date
- March 13, 1985
- 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 |
|---|---|---|
| K875188 | Luer Lock Connectors / Ridig P.V.C.LFJ · Traditional | 03/02/1988SE |
| K871817 | Vas-Cath Peritoneal Dialysis CatheterFJS · Traditional | 07/16/1987SE |
| K871488 | Vas-Cath Permanent Dual Lumen Hemodialysis CathLFJ · Traditional | 06/12/1987SE |
| K871487 | Vas-Cath Permanent Single Lumen Hemodialysis CathLFJ · Traditional | 06/12/1987SE |
| K863982 | Vas-Cath Pericardiocentesis Catheter, Set & TrayJCY · Traditional | 10/24/1986SE |
| K853283 | Vaccess TM 4006LFJ · Traditional | 08/22/1985SE |
| K844854 | Opti-Flow Digital Subtraction Angiography Cat-KitDQO · Traditional | 05/21/1985SE |
| K844800 | Opti-Flow & Opti-Torque Angiographic CathetersDQO · Traditional | 05/16/1985SE |
| K850009 | Evans, Vas-Cath Epidural Needle & CatheterBSO · Traditional | 05/13/1985SE |
| K844433 | Vaccess 2000 Single Lumen Subclavian CannulaLFJ · Traditional | 03/13/1985SE |
Questions and answers
When was Vaccess 3000 Single Lumen Jugular Cannula-Cath cleared by the FDA?
Vaccess 3000 Single Lumen Jugular Cannula-Cath (K844434) received a 510(k) decision of Substantially Equivalent on March 13, 1985, 117 days after the submission was received.
What is the product code of K844434?
The FDA product code is LFJ – Catheter, Subclavian, a Class II (moderate risk) device regulated under 21 CFR 876.5540.