Meadox Exxcel Eptfe Vascular Graft
FDA 510(k) K962433 · Meadox Medicals, Div. Boston Scientific Corp.
510(k) numberK962433
Submission
- Device name
- Meadox Exxcel Eptfe Vascular Graft
- Applicant
- Meadox Medicals, Div. Boston Scientific Corp.
Oakland, NJ, US - Received
- June 24, 1996
- Decision date
- March 17, 1997
- 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 |
|---|---|---|
| K953647 | MS Classique Balloon Catheter W/Hydropass CoatingLIT · Traditional | 05/16/1997SE |
| K960766 | Meadox Medicals, Inc. Expanded PTFE Vascular GraftDYF · Traditional | 03/19/1997ST |
| K961847 | Hemashield Vantage (Vascular GraftDSY · Traditional | 01/22/1997ST |
| K962342 | Hemashield Finesse Ultra-Thin, Knitted Cardiovascular PatchDXZ · Traditional | 09/10/1996SE |
| K955460 | Meadox Medicals, Inc., Expanded & Externally Supported Expanded PTFE Vascular GraftDSY · Traditional | 05/30/1996ST |
| K952884 | Noprofile Olbert Catheter System Balloon Dilatation CatheterLIT · Traditional | 02/21/1996SE |
| K955349 | Hemashield Knitted Double Velour Cardiovascular FabricDXZ · Traditional | 02/14/1996SE |
| K953298 | MS Classique Balloon Diatation CatheterLIT · Traditional | 02/08/1996SE |
| K954848 | Hemashield Microvel Velour Knitted Vascular GraftMAL · Traditional | 02/01/1996ST |
| K953608 | Noprofile Olbert Catheter System Balloon Dilatation CatheterLIT · Traditional | 12/20/1995SE |
Questions and answers
When was Meadox Exxcel Eptfe Vascular Graft cleared by the FDA?
Meadox Exxcel Eptfe Vascular Graft (K962433) received a 510(k) decision of Substantially Equivalent - Subject to Tracking Reg. on March 17, 1997, 266 days after the submission was received.
What is the product code of K962433?
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.