Solicitations › HEALTH AND HUMAN SERVICES, DEPARTMENT OF › NAICS 334516

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

HEALTH AND HUMAN SERVICES, DEPARTMENT OF · Solicitation SSN_CDRH-2026-134633 · NAICS 334516 · Unrestricted (full and open) · Closed

Solicitation details

Solicitation number	SSN_CDRH-2026-134633
Notice ID	c21391b2c9054380b902c7d2a76461d3
Agency	HEALTH AND HUMAN SERVICES, DEPARTMENT OF
Sub-tier	FOOD AND DRUG ADMINISTRATION
Contracting office	FDA OFFICE OF ACQ GRANT SVCS
NAICS code	334516
Product / service code (PSC)	6515
Set-aside	Unrestricted (full and open)
Notice type	Sources Sought
Posted	05 August 2026
Response deadline	10 August 2026 (closed)

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.

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