Dualyse-Cath - Codes #1132.212, 1132.112
FDA 510(k) K896568 · Vygon Corp.
510(k) numberK896568
Submission
- Device name
- Dualyse-Cath - Codes #1132.212, 1132.112
- Applicant
- Vygon Corp.
New York, NY, US - Received
- November 20, 1989
- Decision date
- May 9, 1990
- 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 |
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| K073493 | Hepatostat SetGAM · Traditional | 05/06/2008SE |
| K070705 | Modification to: Latex-Free Bionector, Model# 896.019, 896.039FOZ · Traditional | 11/30/2007SE |
| K061796 | Hepatostat Set, Model 760XGAM · Traditional | 11/02/2006SE |
| K061250 | Multicath ExpertFOZ · Traditional | 09/29/2006SE |
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Questions and answers
When was Dualyse-Cath - Codes #1132.212, 1132.112 cleared by the FDA?
Dualyse-Cath - Codes #1132.212, 1132.112 (K896568) received a 510(k) decision of Substantially Equivalent on May 9, 1990, 170 days after the submission was received.
What is the product code of K896568?
The FDA product code is LFJ – Catheter, Subclavian, a Class II (moderate risk) device regulated under 21 CFR 876.5540.