FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PD CATH
K Number: K053123
·
Decision Mar 29, 2006
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
47
Applicant Total
3
Review Days
142
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
- PD CATH
- K Number
- K053123
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5630
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Med-Conduit, Inc.
- Date Received
- November 7, 2005
- Decision Date
- March 29, 2006
- Product Code
- FJS
- 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 |
|---|---|---|---|
| FJS | Catheter, Peritoneal, Long-Term Indwelling | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FJS), ordered by most recent decision date.
Argyle Peritoneal Dialysis Cathetor and Kit, Ritus Peritoneal Dialysis Catheter Tunneling Tool Kit
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Argyle Peritoneal Dialysis Catheter and Kits, Argyle Presternal Peritoneal Dialysis Catheter and Kits, Argyle Peritoneal Dialysis Accessory Two Part Titanium Luer Adapter, Argyle Adult Peritoneal Dialysis Accessory Titanium Catheter Extender
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
FALLER STYLET
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PS X SERIES (BASIC COMPONENTS AND CATHETER), PD X SERIES (CATHETER WITH ALL COMPONENTS)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
FALLER TROCAR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
VETA PERITONEAL DIALYSIS CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology