Teflon Femoral Catheter Mwi 100,10 &
FDA 510(k) K831828 · Med-West, Inc.
510(k) numberK831828
Submission
- Device name
- Teflon Femoral Catheter Mwi 100,10 &
- Applicant
- Med-West, Inc.
Mchenry, IL, US - Received
- June 7, 1983
- Decision date
- July 7, 1983
- Decision
- Substantially Equivalent (SESE)
- 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 |
| 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 |
More from Meadox Surgimed, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K880877 | Contrast Injection DeviceDXT · Traditional | 05/31/1988SE |
| K880398 | Power Toilet ElevatorINO · Traditional | 03/17/1988SE |
| K874470 | Mwi 400 Wound DressingNAD · Traditional | 12/18/1987SN |
| K872724 | Sheath/DilatorsDRE · Traditional | 09/15/1987SE |
| K854612 | Acute Hemodialysis Tray, CAT.#09-9540-7LFK · Traditional | 01/03/1986SESD |
| K852162 | Mni 400 Injection CapsLFJ · Traditional | 06/12/1985SE |
| K842342 | Mwi 888 & 666 Double Lumen Subclavian · Traditional | 06/14/1984SESP |
| K832124 | CPC, Couble Lumen Cardioplegia-Air AspiDWF · Traditional | 08/12/1983SE |
| K831440 | Single Needle Subclavian Vein MWI250/260FIQ · Traditional | 06/03/1983SE |
| K831401 | Single Needle Subclavian Vein AccessFIQ · Traditional | 06/03/1983SE |
Questions and answers
When was Teflon Femoral Catheter Mwi 100,10 & cleared by the FDA?
Teflon Femoral Catheter Mwi 100,10 & (K831828) received a 510(k) decision of Substantially Equivalent on July 7, 1983, 30 days after the submission was received.
What is the product code of K831828?
The FDA product code is LFK – Catheter, Femoral, a Class II (moderate risk) device regulated under 21 CFR 876.5540.