BioFlo Midline Catheter
FDA 510(k) K150407 · Navilyst Medical, Inc.
510(k) numberK150407
Submission
- Device name
- BioFlo Midline Catheter
- Applicant
- Navilyst Medical, Inc.
Marlborough, MA, US - Received
- February 18, 2015
- Decision date
- May 15, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 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
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|---|---|---|---|
| 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 |
|---|---|---|
| K163452 | PICC Maximal Barrier Nursing KitLJS · Special | 02/03/2017SESK |
| K161866 | BioFlo Midline CatheterFOZ · Traditional | 09/08/2016SE |
| K151239 | Nmi Dual Port IILJT · Traditional | 06/06/2016SE |
| K153228 | NMI Port, NMI Port IILJT · Special | 12/04/2015SE |
| K152409 | Xcela PICC with PASV, Xcela Hybrid PICC with PASV, Xcela Power Injectable PICCLJS · Special | 09/24/2015SE |
| K152069 | Exodus Array Multipurpose Drainage Catheter, Exodus Nuance Nephrostomy Drainage…FGE · Traditional | 09/24/2015SE |
| K150527 | Xcela Power Injectable PICCLJS · Special | 03/31/2015SE |
| K150448 | NMI PICC III and NMI PICC IVLJS · Special | 03/19/2015SE |
| K142616 | PICC Maximal Barrier Nursing KitLJS · Special | 10/14/2014SE |
| K140194 | Namic RCS SyringeFMF · Abbreviated | 04/14/2014SE |
Questions and answers
When was BioFlo Midline Catheter cleared by the FDA?
BioFlo Midline Catheter (K150407) received a 510(k) decision of Substantially Equivalent on May 15, 2015, 86 days after the submission was received.
What is the product code of K150407?
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.