FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH INSERTION STYLETS ACCESSORY
K Number: K051584
·
Decision Oct 6, 2005
Classifications
1
FEI Numbers
55
Registration Numbers
55
Same Product Code
123
Applicant Total
12
Review Days
113
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
- 14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH INSERTION STYLETS ACCESSORY
- K Number
- K051584
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 876.5540
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Kendall
- Date Received
- June 15, 2005
- Decision Date
- October 6, 2005
- 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
Other Clearances by Kendall
| K Number | Device Name | ||
|---|---|---|---|
| K092797 | ACUTE AND CHRONIC CATHETER REPAIR KIT | Nov 19, 2009 | Unknown |
| K062671 | 14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH HEPARIN COATING AND SILVER IMPREGNATED SLEEVE (PALINDROME SAPPHIRE) | Nov 3, 2006 | Unknown |
| K060972 | KEDALL 14.5 FR CHRONIC HEMODIALYSIS CATHETER W/SILVER IMPREGNATED SLEEVE (PALINDROME RUBY) | Aug 4, 2006 | Substantially Equivalent |
| K053410 | GIENTRIPORT WITH UNIVERSAL SINGLE LUMEN ADAPTOR | Jan 6, 2006 | Substantially Equivalent |
| K043272 | PALLINDROME 14.5FR CHRONIC HEMODIALYSIS CATHETER WITH SLOTTED SYMMETRICAL TIP | Dec 22, 2004 | Substantially Equivalent |
| K042461 | KENDALL ARGYLE 2 FR DOUBLE LUMEN NEONATAL/PEDIATRIC PICC, MODEL 43304 | Dec 10, 2004 | Substantially Equivalent |
| K042572 | KENDALL CO2NFIRM NOW CO2 DETECTOR | Nov 5, 2004 | Substantially Equivalent |
| K041914 | PALLINDROME 14.5FR CHRONIC HEMODIALYSIS CATHETER | Sep 27, 2004 | Substantially Equivalent |
| K041006 | TANDEM-CATH HEMODIALYSIS CATHETER, MODEL 10 FR | May 19, 2004 | Substantially Equivalent |
| K040388 | NEXT GENERATION SALEM SUMP | May 17, 2004 | Substantially Equivalent |