FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
CASCADE HEMODIALYSIS/APHERESIS CATHETER
K Number: K130851
·
Decision Jan 9, 2014
Classifications
1
FEI Numbers
55
Registration Numbers
55
Same Product Code
123
Applicant Total
11
Review Days
288
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
- CASCADE HEMODIALYSIS/APHERESIS CATHETER
- K Number
- K130851
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5540
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Unknown
- Statement or Summary
- Summary
- Applicant
- Health Line International Corporation
- Date Received
- March 27, 2013
- Decision Date
- January 9, 2014
- 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 Health Line International Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K222170 | Power Acute Triple Lumen Hemodialysis Catheter | Jan 13, 2023 | Substantially Equivalent |
| K200426 | Acute Dual Lumen Hemodialysis Catheter | Dec 24, 2020 | Unknown |
| K200263 | Health Line CT Midline Catheter | Mar 12, 2020 | Substantially Equivalent |
| K192533 | Health Line CT CVC | Dec 10, 2019 | Substantially Equivalent |
| K160448 | ARTLINE | Jul 12, 2016 | Substantially Equivalent |
| K140270 | NEXUS MIDLINE CT CATHETER | Aug 20, 2014 | Substantially Equivalent |
| K130034 | UNI-PICC | Mar 8, 2013 | Substantially Equivalent |
| K120548 | HLIC NEEDLE-LESS VALVE | May 4, 2012 | Substantially Equivalent |
| K101329 | SYNERGY CT PICC | Aug 19, 2010 | Substantially Equivalent |
| K060352 | HEALTH LINE INTERNATIONAL CORPORATIONS,S IV ADMINISTRATIVE SETS | May 31, 2006 | Substantially Equivalent |