I.V. Catheter Placement Unit
FDA 510(k) K770181 · American Viggo
510(k) numberK770181
Submission
- Device name
- I.V. Catheter Placement Unit
- Applicant
- American Viggo
Mchenry, IL, US - Received
- January 27, 1977
- Decision date
- March 30, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K771339 | Male Luer Lock PlugFPA · Traditional | 08/02/1977SE |
| K770528 | Needle, MembraneFMI · Traditional | 04/29/1977SE |
| K770174 | Luer-Lock Extension SetFPK · Traditional | 03/30/1977SE |
| K770154 | 3-WAY Stopcock with Luer-Lock FittingKGZ · Traditional | 02/28/1977SE |
| K770096 | Epidural Block Procedure PackCAZ · Traditional | 02/25/1977SE |
| K760679 | 4-WAY Stopcock W/7CM Tubing,FMG · Traditional | 12/02/1976SE |
| K760678 | 4-WAY Stopcock W/100 CM Tubing, Luer-LkFMG · Traditional | 12/02/1976SE |
| K760667 | 4-WAY Stopcock W/10 CM Exten. TubingFMG · Traditional | 12/02/1976SE |
| K760666 | 4-WAY Stopcock W/Luer-Lock FittingFMG · Traditional | 12/02/1976SE |
Questions and answers
When was I.V. Catheter Placement Unit cleared by the FDA?
I.V. Catheter Placement Unit (K770181) received a 510(k) decision of Substantially Equivalent on March 30, 1977, 62 days after the submission was received.
What is the product code of K770181?
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.