FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DUALYSE-CATH - CODES #1132.212, 1132.112
K Number: K896568
·
Decision May 9, 1990
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
64
Applicant Total
48
Review Days
170
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- DUALYSE-CATH - CODES #1132.212, 1132.112
- K Number
- K896568
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5540
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Vygon Corp.
- Date Received
- November 20, 1989
- Decision Date
- May 9, 1990
- 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 Vygon Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K121105 | NUTRISAFE 2 FEEDING TUBE | Dec 18, 2012 | Substantially Equivalent |
| K100163 | NUTRISAFE 2 FEEDING TUBES MODEL 362.XXX. 1362.XXX | Oct 13, 2011 | Substantially Equivalent |
| K073493 | HEPATOSTAT SET | May 6, 2008 | Substantially Equivalent |
| K070705 | MODIFICATION TO: LATEX-FREE BIONECTOR, MODEL# 896.019, 896.039 | Nov 30, 2007 | Substantially Equivalent |
| K061796 | HEPATOSTAT SET, MODEL 760X | Nov 2, 2006 | Substantially Equivalent |
| K061250 | MULTICATH EXPERT | Sep 29, 2006 | Substantially Equivalent |
| K060944 | NUTRISAFE 2 | Sep 15, 2006 | Substantially Equivalent |
| K062425 | LIFECATH S PICC AND MIDLINE CATHETER | Sep 15, 2006 | Substantially Equivalent |
| K052564 | VYGON LEADER-FLEX | Apr 5, 2006 | Substantially Equivalent |
| K052881 | VYGON LATEX FREE BIONECTOR | Mar 2, 2006 | Substantially Equivalent |