Reusable PFA Catheter Fabrication

The contract seeks the design and fabrication of reusable Pulsed Field Ablation catheters specifically for use in benchtop hemolysis testing, with an emphasis on ensuring consistent performance and safety through rigorous quality control measures. The work includes electrical validation to confirm proper function under operational conditions and surface assessment to evaluate material integrity and biocompatibility, ensuring the catheters meet required standards for repeated use. All fabricated units must be engineered for durability and reproducibility, with documentation supporting each phase of development and testing. This is a Small Business Set-Aside subcontract under NAICS code 339999, open exclusively to small business concerns as defined by the SBA, and issued by the FDA Office of Acquisitions and Grants Services under the Department of Health and Human Services. Proposals must be submitted by July 20, 2026, and performance is expected to occur without specified geographic constraints. The project's focus is on advancing medical device testing capabilities through reliable, reusable catheter technology, with all deliverables subject to compliance with regulatory and technical specifications established for hemolysis testing environments.