FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NEXUS MIDLINE CT CATHETER
K Number: K140270
·
Decision Aug 20, 2014
Classifications
1
FEI Numbers
204
Registration Numbers
205
Same Product Code
503
Applicant Total
11
Review Days
198
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
- NEXUS MIDLINE CT CATHETER
- K Number
- K140270
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5200
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Health Line International Corporation
- Date Received
- February 3, 2014
- Decision Date
- August 20, 2014
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FOZ), ordered by most recent decision date.
Introcan Safety® Deep Access XL IV Catheter
FDA 510(k)
FDA Class 2
·General Hospital
BD Insyte IV Catheter
FDA 510(k)
FDA Class 2
·General Hospital
Polywin Safety (14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm; 20G x 45mm; 22G x 64mm; 22G x 45mm; 24G x 32mm; 24G x 14mm, 26G x 14mm); Polywin Safety Adva (20G x 45mm; 22G x 64mm; 22G x 45mm ; 24G x 32 mm; 24G x 14mm; 14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm, 26G x 14mm)
FDA 510(k)
FDA Class 2
·General Hospital
SURFLO Hybria Closed System Safety IV Catheter
FDA 510(k)
FDA Class 2
·General Hospital
Polyshield Safety IV Catheters
FDA 510(k)
FDA Class 2
·General Hospital
BD Saf-T-Intima Subcutaneous Catheter System
FDA 510(k)
FDA Class 2
·General Hospital
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 |
| 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 |