Vascuter External Reinforce Triaxial Prostheses
FDA 510(k) K853101 · Cobe Laboratories, Inc.
510(k) numberK853101
Submission
- Device name
- Vascuter External Reinforce Triaxial Prostheses
- Applicant
- Cobe Laboratories, Inc.
Lakewood, CO, US - Received
- July 23, 1985
- Decision date
- February 24, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DSY – Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.3450
- Specialty
- Cardiovascular
- Implant
- Yes
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| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252445 | Fusion Bioline Vascular GraftDSY · Traditional | Maquet Cardiovascular, LLC | 04/27/2026SE |
| K252277 | Spiral Laminar Flow Vascular Arteriovenous Graft (AV0645)DSY · Traditional | Vascular Flow Technologies Limited | 10/20/2025SE |
| K241550 | Gelweave Vascular ProsthesesDSY · Traditional | Vascutek, Ltd. | 02/27/2025SE |
| K241070 | Gelsoft Plus Vascular ProsthesesDSY · Traditional | Vascutek, Ltd. | 11/15/2024SE |
| K231972 | Advanta VXT Vascular Graft, Flixene Vascular GraftDSY · Traditional | Atrium Medical Corporation | 03/28/2024SE |
| K240083 | GORE® PROPATEN® Vascular GraftDSY · Traditional | W. L. Gore & Associates, Inc. | 03/01/2024SE |
| K233783 | exGraft ePTFE Vascular Grafts, exGraft Carbon ePTFE Vascular GraftsDSY · Traditional | Peca Labs, Inc. | 01/17/2024SE |
| K232312 | GORE® PROPATEN® Vascular GraftDSY · Traditional | W. L. Gore & Associates, Inc. | 01/09/2024SE |
| K233551 | GORE® ACUSEAL Vascular GraftDSY · Traditional | W. L. Gore & Associates, Inc. | 12/19/2023SE |
| K231505 | GORE® ACUSEAL Vascular GraftDSY · Special | W. L. Gore & Associates, Inc. | 06/23/2023SE |
More from W. L. Gore & Associates, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K923272 | Cobe Cms-Hf Hollow Fiber Membrane OxygenatorDTZ · Traditional | 05/11/1993SE |
| K900105 | Cobe Spectra Blood Component Separator TherapeuticLKN · Traditional | 03/22/1991SE |
| K905793 | Cobe Centry 2 Bicart Option KitFKP · Traditional | 02/12/1991SE |
| K905388 | Cobe Centrysystem 3 Bicart Option KitFKP · Traditional | 02/11/1991SE |
| K904336 | New Cobe Saturation/Hematocrit MonitorGKF · Traditional | 12/27/1990SE |
| K902631 | Cobe ICU Conversion KitDTN · Traditional | 12/17/1990SE |
| K902437 | Cobe Cardiotomy Reservoir with or Without FilterDTP · Traditional | 12/17/1990SE |
| K904566 | New Cobe Centrysystem(Tm) 100 HG DialyzerFJI · Traditional | 12/12/1990SE |
| K902758 | Cobe Saturation/Hematocrit Monitor W/ Fiber OpticDQA · Traditional | 08/23/1990SE |
| K902759 | Cobe Closed Wound Drainage KitCAC · Traditional | 07/18/1990SE |
Questions and answers
When was Vascuter External Reinforce Triaxial Prostheses cleared by the FDA?
Vascuter External Reinforce Triaxial Prostheses (K853101) received a 510(k) decision of Substantially Equivalent on February 24, 1986, 216 days after the submission was received.
What is the product code of K853101?
The FDA product code is DSY – Prosthesis, Vascular Graft, Of 6mm And Greater Diameter, a Class II (moderate risk) device regulated under 21 CFR 870.3450.