Diastat Vascular Access Graft
FDA 510(k) K955533 · W. L. Gore & Associates, Inc.
510(k) numberK955533
Submission
- Device name
- Diastat Vascular Access Graft
- Applicant
- W. L. Gore & Associates, Inc.
Flagstaff, AZ, US - Received
- December 5, 1995
- Decision date
- May 15, 1996
- Decision
- Substantially Equivalent - Subject to Tracking Reg. (ST)
- Type
- Traditional 510(k)
Device classification
- Product code
- DYF – Prosthesis, Vascular Graft, Of Less Then 6mm Diameter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.3450
- Specialty
- Cardiovascular
- Implant
- Yes
Other 510(k)s with product code DYF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K004012 | Impra Carboflo Eptfe Vascular GraftsDYF · Traditional | Impra, Inc. | 05/14/2001SE |
| K000504 | Advanta Super Soft GraftDYF · Special | Atrium Medical Corp. | 03/01/2000SE |
| K992958 | Advanta Graft (<6MM)DYF · Special | Atrium Medical Corp. | 10/01/1999SE |
| K991683 | PTFE Ringed Gore-Tex Vascular GraftDYF · Traditional | W. L. Gore & Associates, Inc. | 09/08/1999SE |
| K992441 | Advanta GraftDYF · Special | Atrium Medical Corp. | 08/20/1999SE |
| K984183 | Perma-Pass Vascular Graft, 5T Graft,Model 31451DYF · Traditional | Possis Medical, Inc. | 02/01/1999SE |
| K983769 | Distaflo Bypass GraftDYF · Abbreviated | Impra, Inc. | 12/15/1998SE |
| K981076 | Venaflo PTFE Vascular Graft, Venaflo Graft with Carbon, Venaflo Vascular GraftDYF · Traditional | Impra, Inc. | 05/07/1998SE |
| K964877 | Impra Eptfe Arteriovenous Cuffed GraftDYF · Traditional | Impra, Inc. | 03/20/1997ST |
| K960766 | Meadox Medicals, Inc. Expanded PTFE Vascular GraftDYF · Traditional | Meadox Medicals, Div. Boston Scientific Corp. | 03/19/1997ST |
More from Meadox Medicals, Div. Boston Scientific Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K250410 | GORE® Tri-Lobe Balloon CatheterDQY · Traditional | 06/02/2025SE |
| K240083 | GORE® PROPATEN® Vascular GraftDSY · Traditional | 03/01/2024SE |
| K232312 | GORE® PROPATEN® Vascular GraftDSY · Traditional | 01/09/2024SE |
| K233551 | GORE® ACUSEAL Vascular GraftDSY · Traditional | 12/19/2023SE |
| K231505 | GORE® ACUSEAL Vascular GraftDSY · Special | 06/23/2023SE |
| K191773 | GORE BIO-A Tissue ReinforcementOWT · Special | 07/31/2019SE |
| K181940 | GORE SEAMGUARD Bioabsorbable Staple Line ReinforcementOXC · Special | 08/17/2018SE |
| K173333 | GORE ENFORM BiomaterialOXF · Traditional | 04/05/2018SE |
| K163576 | GORE SYNECOR Preperitoneal BiomaterialFTL · Traditional | 05/11/2017SE |
| K170740 | GORE VIABIL Short Wire Biliary EndoprosthesisFGE · Traditional | 05/08/2017SESU |
Questions and answers
When was Diastat Vascular Access Graft cleared by the FDA?
Diastat Vascular Access Graft (K955533) received a 510(k) decision of Substantially Equivalent - Subject to Tracking Reg. on May 15, 1996, 162 days after the submission was received.
What is the product code of K955533?
The FDA product code is DYF – Prosthesis, Vascular Graft, Of Less Then 6mm Diameter, a Class II (moderate risk) device regulated under 21 CFR 870.3450.