Hemo-Cath Silicone Access Catheter
FDA 510(k) K915423 · Medical Components, Inc.
510(k) numberK915423
Submission
- Device name
- Hemo-Cath Silicone Access Catheter
- Applicant
- Medical Components, Inc.
Harleysville, PA, US - Received
- December 2, 1991
- Decision date
- February 2, 1993
- Decision
- Unknown (SESK)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
| K914826 | Akcess-Cath KitLFJ · Traditional | Akcess Medical Products, Inc. | 04/10/1992SESK |
| K910501 | Permanent Silicone CathetersLFJ · Traditional | Akcess Medical Products, Inc. | 04/29/1991SE |
| K905080 | Med-West Dual Lumen Internal Jugular CatheterLFJ · Traditional | Kendall Healthcare Products Co. Div.Of Tyco Health | 01/31/1991SE |
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| 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 Hemo-Cath Silicone Access Catheter cleared by the FDA?
Hemo-Cath Silicone Access Catheter (K915423) received a 510(k) decision of Unknown on February 2, 1993, 428 days after the submission was received.
What is the product code of K915423?
The FDA product code is LFJ – Catheter, Subclavian, a Class II (moderate risk) device regulated under 21 CFR 876.5540.