FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INTEGRAL HEMODIALYSIS CATHETER
K Number: K040260
·
Decision Mar 5, 2004
Classifications
1
FEI Numbers
55
Registration Numbers
55
Same Product Code
123
Applicant Total
1
Review Days
30
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
- INTEGRAL HEMODIALYSIS CATHETER
- K Number
- K040260
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 876.5540
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Arrow Int'L.
- Date Received
- February 4, 2004
- Decision Date
- March 5, 2004
- Product Code
- MSD
- 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 |
|---|---|---|---|
| MSD | Catheter, Hemodialysis, Implanted | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MSD), ordered by most recent decision date.
Hemodialysis Catheter
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
End Cap
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
GlidePath Retro Long-Term Hemodialysis Catheter
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
GlidePath 13F Long-Term Hemodialysis Catheter
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Pristine Long-Term Hemodialysis Catheter
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
GlidePath 7.5F Long-Term Dialysis Catheter
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology