Vascutek Graft Sizer Set
FDA 510(k) K955588 · Carbomedics, Inc.
510(k) numberK955588
Submission
- Device name
- Vascutek Graft Sizer Set
- Applicant
- Carbomedics, Inc.
Austin, TX, US - Received
- December 7, 1995
- Decision date
- March 7, 1996
- Decision
- Substantially Equivalent - Subject to Tracking Reg. (ST)
- 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
Other 510(k)s with product code DSY
| 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 |
|---|---|---|
| K970375 | Annuloflo SystemKRH · Traditional | 07/25/1997ST |
| K964665 | Vascutek Gelweave Vascular Graft (Bifurcated Configuration)DSY · Traditional | 02/19/1997ST |
| K962154 | Carbomedics HandleDTJ · Traditional | 08/27/1996SE |
| K960923 | Carbomedics Mitral RotatorMOP · Traditional | 04/29/1996SE |
| K960706 | Vascutek Vascusoft Plus Vascular GraftDSY · Traditional | 04/25/1996SESP |
| K960169 | Carbomedics Valve TesterDTJ · Traditional | 04/15/1996SE |
| K952184 | Carbomedics Supra-Annular Valve SizerDTI · Traditional | 11/29/1995SE |
| K951368 | Carbomedics Exended Mitral RotatorMOP · Traditional | 06/20/1995SE |
| K942736 | Carbomedics(R) Prosthetic Heart Valve Holder HandleDTJ · Traditional | 07/06/1994SE |
| K934951 | Valve SizerDTI · Traditional | 12/10/1993SE |
Questions and answers
When was Vascutek Graft Sizer Set cleared by the FDA?
Vascutek Graft Sizer Set (K955588) received a 510(k) decision of Substantially Equivalent - Subject to Tracking Reg. on March 7, 1996, 91 days after the submission was received.
What is the product code of K955588?
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.