510(k) Report

FDA applicant

Impra, Inc.

Tempe, AZ29 decisions1979–20012 recalls

FDA records 29 decisions for Impra, Inc. (Tempe, AZ) from 1979 to 2001: 29 510(k) clearances. Most are in product codes DSY (Prosthesis, Vascular Graft, Of 6mm And Greater…) and DYF (Prosthesis, Vascular Graft, Of Less Then 6mm…). 2 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Impra, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Impra, Inc. since 2007.

Recalls per year

2in 2016

2016: 2
2007high 2 (2016) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Impra, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Impra, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • DSYProsthesis, Vascular Graft, Of 6mm And Greater Diameter10decisions
  • DYFProsthesis, Vascular Graft, Of Less Then 6mm Diameter6decisions
  • CACApparatus, Autotransfusion4decisions
  • LFJCatheter, Subclavian2decisions
  • FKXSystem, Peritoneal, Automatic Delivery1decision
  • KNTTubes, Gastrointestinal (And Accessories)1decision

Also: DXE (1), DRE (1), CAR (1), DXZ (1), DQY (1).

Who builds on its devices?

Later devices cite its devices 11 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K791810Vascular Graft Prost. of Expanded PtfeImpra, Inc. · 19795cite it
  • K983861Distaflo Bypass GraftImpra, Inc. · 19983cite it
  • K981079Venaflo Ptfe Vascular Graft, Venaflo Graft with Carbon, Venaflo Vascular GraftImpra, Inc. · 19981cites it
  • K004011Impra Carboflo Vascular Graft, Impra Carboflo Vascular Grafts for a-V AccessImpra, Inc. · 20011cites it
  • K924360Impra Flex Grafts (Various Product Code Numbers)Impra, Inc. · 19921cites it

What has FDA decided for it lately?

  • K004012Impra Carboflo Eptfe Vascular GraftsImpra, Inc. · 2001
  • K004011Impra Carboflo Vascular Graft, Impra Carboflo Vascular Grafts for a-V AccessImpra, Inc. · 2001
  • K991027BI-Directional TunnelerImpra, Inc. · 1999
  • K983769Distaflo Bypass GraftImpra, Inc. · 1998
  • K983861Distaflo Bypass GraftImpra, Inc. · 19982 recalls
  • K983064Impra High Porosity GraftImpra, Inc. · 1998
  • K981079Venaflo Ptfe Vascular Graft, Venaflo Graft with Carbon, Venaflo Vascular GraftImpra, Inc. · 1998
  • K981076Venaflo Ptfe Vascular Graft, Venaflo Graft with Carbon, Venaflo Vascular GraftImpra, Inc. · 1998

All 29 as Impra, Inc. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K983861Bard Distaflo Vascular Bypass Graft; Product Code: DF8006SC; 6 mm x 80 cm. Intended for…Jan 5, 2016Class II
  • K983861Bard Distaflo Vascular Bypass Graft; Product Code: DF6006SC; 8 mm x 60 cm. Intended for…Jan 5, 2016Class II