FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
Acute Dual Lumen Hemodialysis Catheter
K Number: K200426
·
Decision Dec 24, 2020
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
37
Applicant Total
11
Review Days
307
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Basic Information
- Device Name
- Acute Dual Lumen Hemodialysis Catheter
- K Number
- K200426
- 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
- February 21, 2020
- Decision Date
- December 24, 2020
- Product Code
- MPB
- 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 |
|---|---|---|---|
| MPB | Catheter, Hemodialysis, Non-Implanted | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Health Line International Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K222170 | Power Acute Triple Lumen Hemodialysis Catheter | Jan 13, 2023 | Substantially Equivalent |
| 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 |
| K130851 | CASCADE HEMODIALYSIS/APHERESIS CATHETER | Jan 9, 2014 | Unknown |
| 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 |