FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MEDSURG ACUTE DIALYSIS TRAY
K Number: K880778
·
Decision Jul 15, 1988
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
64
Applicant Total
41
Review Days
140
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Basic Information
- Device Name
- MEDSURG ACUTE DIALYSIS TRAY
- K Number
- K880778
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5540
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Medsurg Industries, Inc.
- Date Received
- February 26, 1988
- Decision Date
- July 15, 1988
- Product Code
- LFJ
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LFJ | Catheter, Subclavian | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LFJ), ordered by most recent decision date.
MEDSURG INSERTION TRAY
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
AKCESS0CATH KIT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
AKCESS-CATH
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ULDALL DOUBLE LUMEN HEMODIALYSIS CATHETER SET/TRAY
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SPLITTABLE SHEATH INTRODUCER SET
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
COAXIAL ACUTE CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by Medsurg Industries, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K920780 | MEDSURG INSERTION TRAY | Aug 19, 1994 | Unknown |
| K940175 | MEDSURG STERILE O.R. TOWELS | May 26, 1994 | Substantially Equivalent |
| K934731 | MEDSURG STERILE IMAGING PRODUCTS | Mar 28, 1994 | Substantially Equivalent |
| K925558 | INFILTUBE | Mar 4, 1994 | Substantially Equivalent |
| K934971 | STERILE LAPAROTOMY SPONGES | Feb 7, 1994 | Substantially Equivalent |
| K920421 | MEDSURG MARSHMALLOW TRAY | Dec 13, 1993 | Unknown |
| K920838 | MEDSURG CIRCUMCISION TRAY | Oct 15, 1993 | Substantially Equivalent |
| K931932 | DRESSING CHANGE TRAY-MODIFIED | Aug 27, 1993 | Unknown |
| K914037 | MEDSURG O.R. PROCEDURE TRAY | Jun 22, 1993 | Unknown |
| K914036 | MEDSURG LAPAROSCOPY TRAY | Mar 18, 1992 | Substantially Equivalent |