Advanta Graft
FDA 510(k) K992441 · Atrium Medical Corp.
510(k) numberK992441
Submission
- Device name
- Advanta Graft
- Applicant
- Atrium Medical Corp.
Hudson, NH, US - Received
- July 22, 1999
- Decision date
- August 20, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) statement available from FDA
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 |
| 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 |
| K955533 | Diastat Vascular Access GraftDYF · Traditional | W. L. Gore & Associates, Inc. | 05/15/1996ST |
More from W. L. Gore & Associates, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K231972 | Advanta VXT Vascular Graft, Flixene Vascular GraftDSY · Traditional | 03/28/2024SE |
| K201305 | Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry Suction…CAC · Traditional | 09/03/2021SE |
| K151386 | C-QUR, C-QUR FX, C-QUR TacShield, C-QUR V-Patch, C-QUR CentriFX, C-QUR MosaicFTL · Traditional | 10/22/2015SE |
| K151437 | ProLite Mesh, ProLite Ultra Mesh, ProLoop Mesh PlugFTL · Traditional | 08/27/2015SE |
| K130142 | Flixene Ifg Vascular GraftDSY · Traditional | 03/15/2013SE |
| K130131 | Edrain Chest Drainage SystemBTA · Traditional | 02/28/2013SE |
| K122138 | Atrium Flixene Ifg Vascular GraftDSY · Special | 08/17/2012SE |
| K121070 | C-Qur RPM MeshFTL · Special | 04/26/2012SE |
| K113112 | Clearway RX NB CatheterDQY · Special | 11/17/2011SE |
| K110110 | Atrium Centrilfx MeshFTL · Special | 02/15/2011SE |
Questions and answers
When was Advanta Graft cleared by the FDA?
Advanta Graft (K992441) received a 510(k) decision of Substantially Equivalent on August 20, 1999, 29 days after the submission was received.
What is the product code of K992441?
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.