Pulsed Field Ablation (PFA) System for Non-Clinical Research Use

Agency: HEALTH AND HUMAN SERVICES, DEPARTMENT OF
State: Federal
Type of Government: Federal
FSC Category:
  • 65 - Medical, Dental, and Veterinary Equipment and Supplies
NAICS Category:
  • 334516 - Analytical Laboratory Instrument Manufacturing
Posted Date: Aug 5, 2026
Due Date: Aug 10, 2026
Solicitation No: SSN_CDRH-2026-134633
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Contact information: Please Login to View Page
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Description

Follow
Pulsed Field Ablation (PFA) System for Non-Clinical Research Use
Active
Contract Opportunity
Notice ID
SSN_CDRH-2026-134633
Related Notice
Department/Ind. Agency
HEALTH AND HUMAN SERVICES, DEPARTMENT OF
Sub-tier
FOOD AND DRUG ADMINISTRATION
Office
FDA OFFICE OF ACQ GRANT SVCS
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General Information
  • Contract Opportunity Type: Sources Sought (Original)
  • Original Published Date: Aug 05, 2026 11:23 am EDT
  • Original Response Date: Aug 10, 2026 10:30 am EDT
  • Inactive Policy: 15 days after response date
  • Original Inactive Date: Aug 25, 2026
  • Initiative:
    • None
Classification
  • Original Set Aside:
  • Product Service Code: 6515 - MEDICAL AND SURGICAL INSTRUMENTS, EQUIPMENT, AND SUPPLIES
  • NAICS Code:
    • 334516 - Analytical Laboratory Instrument Manufacturing
  • Place of Performance:
Description

The U.S. Food and Drug Administration is issuing this Sources Sought Notice for market research purposes to identify qualified sources capable of providing a complete, off-the-shelf Pulsed Field Ablation (PFA) system for non-clinical research use. The required system includes a PFA generator, compatible catheters, all necessary accessories and cables, on-site installation, startup and operational verification, training, documentation, warranty coverage, and technical support. The proposed system must be FDA-approved or cleared for clinical use in the United States for the treatment of atrial fibrillation or other cardiac arrhythmias.



This notice is not a solicitation and does not constitute a commitment by the Government to issue a solicitation or make an award. Interested vendors should review the attached Sources Sought Notice and submit the required Vendor Response Form and supporting capability information by the response deadline stated in the posting.


Attachments/Links
Contact Information
Contracting Office Address
  • 11601 Landsdown St Floor 13
  • Rockville , MD 20852
  • USA
Primary Point of Contact
Secondary Point of Contact


History
  • Aug 05, 2026 11:23 am EDTSources Sought (Original)
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