Impra High Porosity Graft
by Impra, Inc.
510(k) K983064
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK983064 | Date19 Nov 1998 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- DSY
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.3450
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 26 Sep 2026
The Impra High Porosity Graft is a vascular graft prosthesis, used for vascular grafting procedures. It is made of a high porosity material and is designed for use in cardiovascular applications. The device is classified as a Prosthesis, Vascular Graft, Of 6mm And Greater Diameter.
The Impra High Porosity Graft is supplied as a single-use device and is intended for use in cardiovascular procedures. It has been found to be substantially equivalent to the Impra ePTFE Vascular Graft and has been cleared under the FDA 510K process, with the regulation number 870.3450. The device is available in various sizes, but specific sizes are not listed in the provided data.
Other devices from Impra, Inc.
Questions
AI-generated answers, 26 Sep 2026
What is the Impra High Porosity Graft used for?
The Impra High Porosity Graft is used for vascular grafting procedures in cardiovascular applications.
Is the Impra High Porosity Graft a single-use device?
Yes, the Impra High Porosity Graft is supplied as a single-use device and is intended for use in cardiovascular procedures.
What sizes is the Impra High Porosity Graft available in?
The Impra High Porosity Graft is available in various sizes, but specific sizes are not listed in the provided data.
What is the regulatory status of the Impra High Porosity Graft?
The Impra High Porosity Graft has been cleared under the FDA 510K process, with the regulation number 870.3450, and is classified as substantially equivalent to the Impra ePTFE Vascular Graft.