The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource ClearSafe Blood Control I.V. Safety Catheter
FDA 510(k) K223788 · Medsource International, LLC
510(k) numberK223788
Submission
- Device name
- The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource ClearSafe Blood Control I.V. Safety Catheter
- Applicant
- Medsource International, LLC
Chanhassen, MN, US - Received
- December 19, 2022
- Decision date
- September 15, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 |
|---|---|---|
| K161779 | MedSource TrueSafe Safety IV Catheter, MedSource TrueSafe Comfort Safety IV CatheterFOZ · Traditional | 11/03/2016SE |
| K150611 | MedSource ClearSafe Safety IV CatheterFOZ · Traditional | 07/15/2015SE |
| K150333 | MedSource Sharps DartMMK · Traditional | 05/08/2015SE |
| K140442 | Medsource Selectable IV SetLHI · Special | 04/22/2014SE |
| K140402 | Medsource IV Administration Set 72 Medsource IV Administration Set, Needleless Male…LHI · Special | 04/03/2014SE |
| K131555 | Medsource IV Safety CatheterFOZ · Traditional | 01/31/2014SE |
| K120424 | Medsource IV Adminstration SetLHI · Traditional | 07/11/2012SE |
| K080339 | Medsource Endotracheal Tube (with and Without Cuff)BTR · Traditional | 10/27/2008SE |
| K081516 | Medsource CPR Mask with & Without Oxygen PortCBP · Traditional | 08/26/2008SE |
Questions and answers
When was The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource ClearSafe Blood Control I.V. Safety Catheter cleared by the FDA?
The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource ClearSafe Blood Control I.V. Safety Catheter (K223788) received a 510(k) decision of Substantially Equivalent on September 15, 2023, 270 days after the submission was received.
What is the product code of K223788?
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.