I.V. Catheter System
FDA 510(k) K980493 · Johnson & Johnson Medical, Inc.
510(k) numberK980493
Submission
- Device name
- I.V. Catheter System
- Applicant
- Johnson & Johnson Medical, Inc.
Arlington, TX, US - Received
- February 9, 1998
- Decision date
- April 28, 1998
- 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 |
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| K001690 | Protectiv Safety Blood Collection NeedleFMI · Traditional | 07/31/2000SE |
| K982641 | Advanced Nibp ModuleDXN · Traditional | 03/29/1999SE |
| K983362 | Nu-Gel * Wound DressingMGQ · Traditional | 12/16/1998SE |
| K982597 | Fibrcol Plus Collagen Wound Dressing with AlginateKGN · Traditional | 08/20/1998SE |
| K974080 | Critikon Soft Blood Pressure CuffDXQ · Traditional | 05/18/1998SE |
| K972498 | Observer * Central StationDSI · Traditional | 02/17/1998SE |
| K973699 | Ultralon Powder Free Latex Surgical GloveKGO · Traditional | 12/16/1997SE |
Questions and answers
When was I.V. Catheter System cleared by the FDA?
I.V. Catheter System (K980493) received a 510(k) decision of Substantially Equivalent on April 28, 1998, 78 days after the submission was received.
What is the product code of K980493?
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.