FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Health Line CT Midline Catheter
K Number: K200263
·
Decision Mar 12, 2020
Classifications
1
FEI Numbers
204
Registration Numbers
205
Same Product Code
503
Applicant Total
11
Review Days
38
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Basic Information
- Device Name
- Health Line CT Midline Catheter
- K Number
- K200263
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 880.5200
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Health Line International Corporation
- Date Received
- February 3, 2020
- Decision Date
- March 12, 2020
- Product Code
- FOZ
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | FDA class 2 | General Hospital |
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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 |
| K200426 | Acute Dual Lumen Hemodialysis Catheter | Dec 24, 2020 | Unknown |
| 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 |