Vas-Cath Catheter Repair Kit
FDA 510(k) K883768 · Vas-Cath, Inc.
510(k) numberK883768
Submission
- Device name
- Vas-Cath Catheter Repair Kit
- Applicant
- Vas-Cath, Inc.
Mississauga, Ontario, CA - Received
- September 6, 1988
- Decision date
- November 14, 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 |
|---|---|---|
| K973013 | Opti-Plast (Centurion) 5.5F Angioplasty CatheterLIT · Traditional | 06/19/1998SE |
| K965178 | Niagara Dual Lumen CatheterMPB · Traditional | 08/19/1997SE |
| K964881 | Ultraverse Pta CatheterLIT · Traditional | 05/28/1997SE |
| K970725 | Opti-Plast XL 5.5 F Pta CatheterLIT · Traditional | 05/09/1997SE |
| K941706 | Opti-Plast Angioplasty CatheterLIT · Traditional | 10/18/1994SE |
| K925485 | Vas-Cath Inc. Opti-Plast Angioplasty CatheterLIT · Traditional | 03/10/1994SE |
| K933483 | Opti-Plast 5F Pta CathetersLIT · Traditional | 09/24/1993SE |
| K914210 | Vas-Cath Dualator(Tm) Vessel DilatorFKA · Traditional | 07/01/1993SE |
| K914162 | Vas-Cath Flexxicon 2 Dual Lumen Dialysis CathetersLFJ · Traditional | 07/01/1993SE |
| K914976 | Opti-Plast 5F Pta Catheters, ModificationLIT · Traditional | 01/27/1992SE |
Questions and answers
When was Vas-Cath Catheter Repair Kit cleared by the FDA?
Vas-Cath Catheter Repair Kit (K883768) received a 510(k) decision of Substantially Equivalent on November 14, 1988, 69 days after the submission was received.
What is the product code of K883768?
The FDA product code is LFJ – Catheter, Subclavian, a Class II (moderate risk) device regulated under 21 CFR 876.5540.