Viapic Central Line Catheter
FDA 510(k) K860290 · Parke-Davis Co.
510(k) numberK860290
Submission
- Device name
- Viapic Central Line Catheter
- Applicant
- Parke-Davis Co.
Rochester, MI, US - Received
- January 28, 1986
- Decision date
- March 18, 1986
- 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 |
|---|---|---|
| K861725 | Intracath Intravenous Catheter Placement UnitFOZ · Traditional | 12/04/1986SE |
| K862119 | Deseret Flo-Thru Injectate Temperature SensorDYG · Traditional | 08/29/1986SE |
| K855120 | Ati Disposable Biological Test PackFRC · Traditional | 06/18/1986SE |
| K860570 | Angio-Flo Continuous Arterial Cath Flush DeviceKRA · Traditional | 03/31/1986SE |
| K852192 | Disposable Steam Biological Test PackFRC · Traditional | 11/01/1985SE |
| K841967 | Deseret Thermodilution Cardiac OutputDXG · Traditional | 08/19/1985SE |
| K851327 | Deseret Arterial CatheterFOZ · Traditional | 06/14/1985SE |
| K852078 | Spectrum(Tentative)FOZ · Traditional | 06/07/1985SE |
| K844840 | Deseret Introducer SetDYB · Traditional | 05/16/1985SE |
| K850505 | Deseret Epidural Catheter W/Toughy-Borst AdapterBSO · Traditional | 03/11/1985SE |
Questions and answers
When was Viapic Central Line Catheter cleared by the FDA?
Viapic Central Line Catheter (K860290) received a 510(k) decision of Substantially Equivalent on March 18, 1986, 49 days after the submission was received.
What is the product code of K860290?
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.