Amecath CVC and Amecath Pressure CVC Short Term Single and Multi-Lumen Catherization Kits
FDA 510(k) K110794 · Ameco Medical Industries
510(k) numberK110794
Submission
- Device name
- Amecath CVC and Amecath Pressure CVC Short Term Single and Multi-Lumen Catherization Kits
- Applicant
- Ameco Medical Industries
Mason, NH, US - Received
- March 22, 2011
- Decision date
- December 21, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
|---|---|---|
| K152819 | Amecath Peripheral inserted Central Venous Catheter SetsLJS · Traditional | 02/05/2016SE |
| K131144 | Ameco Sheath IntroducerDYB · Traditional | 08/15/2013SE |
| K131814 | Amecath Dual Lumen Implanted Hemodialysis CatheterMSD · Special | 07/26/2013SESK |
| K123943 | Amecath Dual Lumen Hemodialysis CatheterMSD · Traditional | 04/02/2013SE |
| K110793 | Amecath and Amecath Uniqath Soft Short Term Dual Hemodialysis Catheterization KitsMPB · Traditional | 12/16/2011SE |
Questions and answers
When was Amecath CVC and Amecath Pressure CVC Short Term Single and Multi-Lumen Catherization Kits cleared by the FDA?
Amecath CVC and Amecath Pressure CVC Short Term Single and Multi-Lumen Catherization Kits (K110794) received a 510(k) decision of Substantially Equivalent on December 21, 2011, 274 days after the submission was received.
What is the product code of K110794?
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.