Medsurg Insertion Tray
FDA 510(k) K920780 · Medsurg Industries, Inc.
510(k) numberK920780
Submission
- Device name
- Medsurg Insertion Tray
- Applicant
- Medsurg Industries, Inc.
Herndon, VA, US - Received
- February 20, 1992
- Decision date
- August 19, 1994
- Decision
- Unknown (SEKD)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
|---|---|---|---|
| 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 |
| K915423 | Hemo-Cath Silicone Access CatheterLFJ · Traditional | Medical Components, Inc. | 02/02/1993SESK |
| 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 |
More from Kendall Healthcare Products Co. Div.Of Tyco Health
| 510(k) | Device | Decision |
|---|---|---|
| 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 |
| K893938 | Continuous Epidural Anesthesia TrayCAZ · Traditional | 08/07/1989SE |
Questions and answers
When was Medsurg Insertion Tray cleared by the FDA?
Medsurg Insertion Tray (K920780) received a 510(k) decision of Unknown on August 19, 1994, 911 days after the submission was received.
What is the product code of K920780?
The FDA product code is LFJ – Catheter, Subclavian, a Class II (moderate risk) device regulated under 21 CFR 876.5540.