Continuous Arteriovenous Hemofiltration Cath. Kits
FDA 510(k) K915215 · Akcess Medical Products, Inc.
510(k) numberK915215
Submission
- Device name
- Continuous Arteriovenous Hemofiltration Cath. Kits
- Applicant
- Akcess Medical Products, Inc.
New Brunswick, NJ, US - Received
- November 18, 1991
- Decision date
- March 27, 1992
- Decision
- Unknown (SESK)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
| 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 |
| K880775 | Continuous Arterial/Venous Hemofiltration TrayLFK · Traditional | Medsurg Industries, Inc. | 07/25/1988SESD |
| 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 |
|---|---|---|
| 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 |
| K911333 | Right Atrial CathetersDQY · Traditional | 09/23/1991SE |
Questions and answers
When was Continuous Arteriovenous Hemofiltration Cath. Kits cleared by the FDA?
Continuous Arteriovenous Hemofiltration Cath. Kits (K915215) received a 510(k) decision of Unknown on March 27, 1992, 130 days after the submission was received.
What is the product code of K915215?
The FDA product code is LFK – Catheter, Femoral, a Class II (moderate risk) device regulated under 21 CFR 876.5540.