Health Line CT Midline Catheter
FDA 510(k) K200263 · Health Line International Corporation
510(k) numberK200263
Submission
- Device name
- Health Line CT Midline Catheter
- Applicant
- Health Line International Corporation
Salt Lake City, UT, US - Received
- February 3, 2020
- Decision date
- March 12, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FOZ – Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5200
- Specialty
- General Hospital
Other 510(k)s with product code FOZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260432 | Ruby Intravascular CatheterFOZ · Traditional | Venocare, Inc. | 09/02/2026SE |
| K260165 | Unimpregnated Central Venous CatheterFOZ · Traditional | Spectrum Vascular | 08/10/2026SE |
| K261041 | ClearSafe Closed SystemFOZ · Traditional | MedSource Labs, LLC | 07/10/2026SE |
| K260539 | MedSource QuickSafe Safety IV Catheter; MedSource PurSafe Safety IV CatheterFOZ · Traditional | MedSource Labs, LLC | 07/09/2026SE |
| K253235 | Introcan Safety® Deep Access XL IV CatheterFOZ · Traditional | B.Braun Medical, Inc. | 05/15/2026SE |
| K252137 | BD Insyte IV CatheterFOZ · Traditional | Becton Dickinson Infusion Therapy Systems, Inc. | 04/02/2026SE |
| K252513 | Polywin Safety (14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm; 20G x 45mm; 22G x 64mm…FOZ · Special | Poly Medicure Limited | 04/01/2026SE |
| K252398 | SURFLO Hybria Closed System Safety IV CatheterFOZ · Traditional | Terumo Medical Products (Hangzhou) Co., Ltd. | 12/17/2025SE |
| K252677 | Polyshield Safety IV CathetersFOZ · Special | Poly Medicure Limited | 11/05/2025SE |
| K251422 | BD Saf-T-Intima Subcutaneous Catheter SystemFOZ · Traditional | Becton Dickinson Infusion Therapy Systems, Inc. | 10/08/2025SE |
More from Becton Dickinson Infusion Therapy Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K261950 | Health Line Tearaway IntroducerDYB · Traditional | 06/22/2026SE |
| K222170 | Power Acute Triple Lumen Hemodialysis CatheterNIE · Traditional | 01/13/2023SE |
| K200426 | Acute Dual Lumen Hemodialysis CatheterMPB · Traditional | 12/24/2020SESK |
| K192533 | Health Line CT CVCFOZ · Traditional | 12/10/2019SE |
| K160448 | ArtlineDQY · Traditional | 07/12/2016SE |
| K140270 | Nexus Midline CT CatheterFOZ · Traditional | 08/20/2014SE |
| K130851 | Cascade Hemodialysis/Apheresis CatheterMSD · Traditional | 01/09/2014SESK |
| K130034 | Uni-PiccLJS · Traditional | 03/08/2013SE |
| K120548 | Hlic Needle-Less ValveFPA · Traditional | 05/04/2012SE |
| K101329 | Synergy CT PiccLJS · Traditional | 08/19/2010SE |
Questions and answers
When was Health Line CT Midline Catheter cleared by the FDA?
Health Line CT Midline Catheter (K200263) received a 510(k) decision of Substantially Equivalent on March 12, 2020, 38 days after the submission was received.
What is the product code of K200263?
The FDA product code is FOZ – Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days, a Class II (moderate risk) device regulated under 21 CFR 880.5200.