Solicitations › HEALTH AND HUMAN SERVICES, DEPARTMENT OF › NAICS 334510

Pulsed Field Ablation System (PFA)

HEALTH AND HUMAN SERVICES, DEPARTMENT OF · Solicitation 75F40126Q00391 · NAICS 334510 · No Set aside used · Closed

Solicitation details

Solicitation number	75F40126Q00391
Notice ID	df2b9477499441e0aeca62280295bb72
Agency	HEALTH AND HUMAN SERVICES, DEPARTMENT OF
Sub-tier	FOOD AND DRUG ADMINISTRATION
Contracting office	FDA OFFICE OF ACQ GRANT SVCS
NAICS code	334510
Product / service code (PSC)	6515
Set-aside	No Set aside used
Notice type	Solicitation
Posted	25 August 2026
Response deadline	03 September 2026 (closed)

Description

The U.S. Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH), has a requirement for one complete, off-the-shelf Pulsed Field Ablation (PFA) system for use in a non-clinical research environment. The required system includes a PFA generator, five compatible clinical PFA catheters, all required accessories, cables, connectors, applicable software and licenses, setup/startup assistance, functional testing, training, warranty coverage, and technical support, in accordance with Attachment 1 Statement of Work (SOW). Questions are due Thursday, August 27, 2026, at 10:30 a.m. ET. Offers are due Thursday, September 3, 2026, at 2:30 p.m. ET.

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