Medcomp C.A.V.H. Catheter
FDA 510(k) K862771 · Medical Components, Inc.
510(k) numberK862771
Submission
- Device name
- Medcomp C.A.V.H. Catheter
- Applicant
- Medical Components, Inc.
Harleysville, PA, US - Received
- July 22, 1986
- Decision date
- August 6, 1986
- 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 |
|---|---|---|
| K250836 | 14F Duo-Flow® Side X Side Double Lumen CatheterMPB · Traditional | 08/12/2025SE |
| K141633 | Pro-Picc with Valve TechnologyLJS · Traditional | 09/29/2014SE |
| K132880 | Medcomp Power Injectable Safety Huber NeedleFPA · Traditional | 01/08/2014SE |
| K131687 | 6F X 60CM Triple Pro-Line CT Basic Ir SetLJS · Traditional | 08/16/2013SE |
| K130687 | 2F & 3F Vascu-Sheath Tearaway IntroducerDYB · Traditional | 08/15/2013SE |
| K130923 | 5F Dignity CT Titanium PortLJT · Traditional | 07/31/2013SE |
| K124046 | Valved Tearaway Introducer Generation IIDYB · Traditional | 06/03/2013SE |
| K123617 | 3F Pro-PiccLJS · Traditional | 05/15/2013SE |
| K122423 | Vasu-PiccLJS · Traditional | 12/12/2012SE |
| K121848 | Split Cath III 24CM Split Cath III 24CM Split Cath III 32CM Cath III 36CM Split Cath III…MSD · Special | 09/21/2012SESK |
Questions and answers
When was Medcomp C.A.V.H. Catheter cleared by the FDA?
Medcomp C.A.V.H. Catheter (K862771) received a 510(k) decision of Substantially Equivalent on August 6, 1986, 15 days after the submission was received.
What is the product code of K862771?
The FDA product code is LFK – Catheter, Femoral, a Class II (moderate risk) device regulated under 21 CFR 876.5540.