Vas-Cath Trifusion Triple Lumen Infusion Catheter
FDA 510(k) K895597 · Vas-Cath, Inc.
510(k) numberK895597
Submission
- Device name
- Vas-Cath Trifusion Triple Lumen Infusion Catheter
- Applicant
- Vas-Cath, Inc.
Mississauga, Ontario, CA - Received
- September 18, 1989
- Decision date
- September 12, 1990
- 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 |
|---|---|---|
| K973013 | Opti-Plast (Centurion) 5.5F Angioplasty CatheterLIT · Traditional | 06/19/1998SE |
| K965178 | Niagara Dual Lumen CatheterMPB · Traditional | 08/19/1997SE |
| K964881 | Ultraverse Pta CatheterLIT · Traditional | 05/28/1997SE |
| K970725 | Opti-Plast XL 5.5 F Pta CatheterLIT · Traditional | 05/09/1997SE |
| K941706 | Opti-Plast Angioplasty CatheterLIT · Traditional | 10/18/1994SE |
| K925485 | Vas-Cath Inc. Opti-Plast Angioplasty CatheterLIT · Traditional | 03/10/1994SE |
| K933483 | Opti-Plast 5F Pta CathetersLIT · Traditional | 09/24/1993SE |
| K914210 | Vas-Cath Dualator(Tm) Vessel DilatorFKA · Traditional | 07/01/1993SE |
| K914162 | Vas-Cath Flexxicon 2 Dual Lumen Dialysis CathetersLFJ · Traditional | 07/01/1993SE |
| K914976 | Opti-Plast 5F Pta Catheters, ModificationLIT · Traditional | 01/27/1992SE |
Questions and answers
When was Vas-Cath Trifusion Triple Lumen Infusion Catheter cleared by the FDA?
Vas-Cath Trifusion Triple Lumen Infusion Catheter (K895597) received a 510(k) decision of Substantially Equivalent on September 12, 1990, 359 days after the submission was received.
What is the product code of K895597?
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.