Impra Flex Grafts (Various Product Code Numbers)
FDA 510(k) K924360 · Impra, Inc.
510(k) numberK924360
Submission
- Device name
- Impra Flex Grafts (Various Product Code Numbers)
- Applicant
- Impra, Inc.
Tempe, AZ, US - Received
- August 28, 1992
- Decision date
- November 25, 1992
- Decision
- Unknown (SESP)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
| 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 |
|---|---|---|
| K004012 | Impra Carboflo Eptfe Vascular GraftsDYF · Traditional | 05/14/2001SE |
| K004011 | Impra Carboflo Vascular Graft, Impra Carboflo Vascular Grafts for A-V AccessDSY · Traditional | 03/27/2001SE |
| K991027 | Bi-Directional TunnelerDSY · Special | 04/22/1999SE |
| K983769 | Distaflo Bypass GraftDYF · Abbreviated | 12/15/1998SE |
| K983861 | Distaflo Bypass GraftDSY · Abbreviated | 11/24/1998SE |
| K983064 | Impra High Porosity GraftDSY · Traditional | 11/19/1998SE |
| K981079 | Venaflo PTFE Vascular Graft, Venaflo Graft with Carbon, Venaflo Vascular GraftDSY · Traditional | 05/07/1998SE |
| K981076 | Venaflo PTFE Vascular Graft, Venaflo Graft with Carbon, Venaflo Vascular GraftDYF · Traditional | 05/07/1998SE |
| K971192 | Impra Eptfe Arteriovenous Cuffed GraftDSY · Traditional | 04/15/1997ST |
| K964877 | Impra Eptfe Arteriovenous Cuffed GraftDYF · Traditional | 03/20/1997ST |
Questions and answers
When was Impra Flex Grafts (Various Product Code Numbers) cleared by the FDA?
Impra Flex Grafts (Various Product Code Numbers) (K924360) received a 510(k) decision of Unknown on November 25, 1992, 89 days after the submission was received.
What is the product code of K924360?
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.