HS Code for Cardiac Pacemakers
The HS Code for cardiac pacemakers is 902150. The MFN duty rate for importing to the US is Free.
| HS Code (6-digit) | 902150 |
|---|---|
| US Duty Rate (MFN) | Free |
| EU Duty Rate (MFN) | 0% |
| Chapter | 90 |
| Heading | 9021 |
| Last Updated | 2026-05 |
Description
Pacemakers for stimulating heart muscles
HS Code 902150 covers cardiac pacemakers for stimulating heart muscles with a US MFN duty rate of Free.
Frequently Asked Questions
What are the specific United States import documentation requirements for HTS 902150 Cardiac Pacemakers?
The U.S. Food and Drug Administration (FDA) requires a Premarket Approval (PMA) or 510(k) clearance for cardiac pacemakers prior to importation. You must present the FDA entry number and may need to submit an Importer's Entry Notice (Form FDA 2877) with your customs filing. Shipments arriving without prior FDA authorization will be detained at the port of entry.
How does the presence of radioactive isotopes in a cardiac pacemaker affect its HTS classification?
Cardiac pacemakers containing a radioactive power source, such as a plutonium battery, are specifically excluded from HTS 9021.50. They must be classified elsewhere, typically under 9021.90 as other parts and accessories, or potentially under Chapter 28 or 98.01, depending on the nature of the radioactive material and its packaging.
Similar & Confused HTS Codes
Cardiac pacemakers (9021.50) are most often confused with parts and accessories of other medical devices. Components like external programmers or telemetry modules for pacemaker systems are typically classified under 9018.90 (Other instruments and appliances). Additionally, non-implantable, external heart rate monitoring electrodes fall under 9018.19. It is critical to distinguish the implantable pulse generator itself from its accessories and from non-implantable cardiac monitoring equipment to ensure correct duty application.
Related HS Codes
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