FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ARTLINE
K Number: K160448
·
Decision Jul 12, 2016
Classifications
1
FEI Numbers
276
Registration Numbers
277
Same Product Code
889
Applicant Total
11
Review Days
145
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
- ARTLINE
- K Number
- K160448
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Health Line International Corporation
- Date Received
- February 18, 2016
- Decision Date
- July 12, 2016
- Product Code
- DQY
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| DQY | Catheter, Percutaneous | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DQY), ordered by most recent decision date.
Amplatzer TorqVue Exchange System
FDA 510(k)
FDA Class 2
·Cardiovascular
Perfect-O Ostial Positioning Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
Amplatzer TorqVue Delivery System
FDA 510(k)
FDA Class 2
·Cardiovascular
Teleport Glide Microcatheter
FDA 510(k)
FDA Class 2
·Cardiovascular
Amplatzer Trevisio Intravascular Delivery System; 9-ATV06F45/609-ATV07F45/609-ATV07F45/809-ATV08F45/609-ATV08F45/809-ATV09F45/809-ATV10F45/809-ATV12F45/80
FDA 510(k)
FDA Class 2
·Cardiovascular
C320LBB Delivery System (C320LBBS45), C320LBB Delivery System (C320LBBS48), C320LBB Delivery System (C320LBBL45), C320LBB Delivery System (C320LBBL48)
FDA 510(k)
FDA Class 2
·Cardiovascular
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 |
| 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 |