Continuous Arterial/Venous Hemofiltration Tray
FDA 510(k) K880775 · Medsurg Industries, Inc.
510(k) numberK880775
Submission
- Device name
- Continuous Arterial/Venous Hemofiltration Tray
- Applicant
- Medsurg Industries, Inc.
Herndon, VA, US - Received
- February 26, 1988
- Decision date
- July 25, 1988
- Decision
- Unknown (SESD)
- Type
- Traditional 510(k)
Device classification
- Product code
- LFK – Catheter, Femoral
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5540
- Specialty
- Gastroenterology, Urology
- Implant
- Yes
- Life-sustaining
- Yes
Other 510(k)s with product code LFK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K971897 | Continuous Arteriovenous Hemofiltration Catheter 10 FR (Cavh)LFK · Traditional | Medron, Inc. | 10/21/1997SE |
| K914936 | Continuous Arteriovenous Hemofiltration Cath SetLFK · Traditional | Akcess Medical Products, Inc. | 04/23/1992SESK |
| K915215 | Continuous Arteriovenous Hemofiltration Cath. KitsLFK · Traditional | Akcess Medical Products, Inc. | 03/27/1992SESK |
| K891764 | FC-101 Femoral Catheter Guide WireLFK · Traditional | Akcess Medical Products, Inc. | 04/07/1989SE |
| K891763 | FC-100 Femoral CatheterLFK · Traditional | Akcess Medical Products, Inc. | 04/07/1989SE |
| K890717 | Modification Hemofiltration Catheter HF-100LFK · Traditional | Vas-Cath, Inc. | 04/05/1989SE |
| K882466 | Vas-Cath Pediatric Hemofiltration CatheterLFK · Traditional | Vas-Cath, Inc. | 07/13/1988SE |
| K865096 | New Second French Size Mahurkar CatheterLFK · Traditional | Quinton, Inc. | 02/18/1987SESD |
| K863218 | Cytostatic Filtration SetLFK · Traditional | Meadox Surgimed, Inc. | 02/12/1987SE |
| K862771 | Medcomp C.A.V.H. CatheterLFK · Traditional | Medical Components, Inc. | 08/06/1986SE |
More from Medical Components, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K920780 | Medsurg Insertion TrayLFJ · Traditional | 08/19/1994SEKD |
| K940175 | Medsurg Sterile O.R. TowelsKKX · Traditional | 05/26/1994SE |
| K934731 | Medsurg Sterile Imaging ProductsFMP · Traditional | 03/28/1994SE |
| K925558 | InfiltubeHIF · Traditional | 03/04/1994SE |
| K934971 | Sterile Laparotomy SpongesGDY · Traditional | 02/07/1994SE |
| K920421 | Medsurg Marshmallow TrayGAT · Traditional | 12/13/1993SESK |
| K920838 | Medsurg Circumcision TrayHFK · Traditional | 10/15/1993SE |
| K931932 | Dressing Change Tray-ModifiedMCY · Traditional | 08/27/1993SEKD |
| K914037 | Medsurg O.R. Procedure TrayLRO · Traditional | 06/22/1993SEKD |
| K914036 | Medsurg Laparoscopy TrayLRO · Traditional | 03/18/1992SE |
Questions and answers
When was Continuous Arterial/Venous Hemofiltration Tray cleared by the FDA?
Continuous Arterial/Venous Hemofiltration Tray (K880775) received a 510(k) decision of Unknown on July 25, 1988, 150 days after the submission was received.
What is the product code of K880775?
The FDA product code is LFK – Catheter, Femoral, a Class II (moderate risk) device regulated under 21 CFR 876.5540.