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FDA PMA

Device, hemostasis, vascular

PMA Number: P040044 · 2026-05-14

ApplicantCordis US Corporation
Decision Date2026-05-14
PMA NumberP040044
Product CodeMGB
Device ClassClass 3
Medical SpecialtyU
Advisory CommitteeCV

Device Summary

Device, hemostasis, vascular is a medical device manufactured by Cordis US Corporation. It received FDA Premarket Approval (PMA) on 2026-05-14 under PMA number P040044. The device is classified under FDA product code MGB. It was reviewed by the CV advisory panel. This device is classified as Class III by the FDA. Class III devices subject to the most stringent regulatory controls. These devices generally require premarket approval (PMA) because they support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential unreasonable risk of illness or injury. PMA is the most stringent type of device marketing application required by the FDA. The device falls under the medical specialty of U. Unlike 510(k) clearance, which demonstrates substantial equivalence to a predicate device, PMA requires the manufacturer to submit clinical trial data demonstrating the safety and effectiveness of the device. PMA is generally required for Class III devices that support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential unreasonable risk of illness or injury.

Frequently Asked Questions

What is Device, hemostasis, vascular?

Device, hemostasis, vascular is a medical device that received FDA Premarket Approval (PMA) on 2026-05-14. It is manufactured by Cordis US Corporation. The PMA number is P040044.

When did Device, hemostasis, vascular receive FDA PMA approval?

Device, hemostasis, vascular received FDA PMA approval on 2026-05-14, under approval number P040044.

What company makes Device, hemostasis, vascular?

Device, hemostasis, vascular is manufactured by Cordis US Corporation.

What is the difference between PMA and 510(k)?

PMA (Premarket Approval) is the FDA process for evaluating Class III medical devices. Unlike 510(k) clearance, which demonstrates substantial equivalence to a predicate device, PMA requires the manufacturer to provide clinical data proving safety and effectiveness. PMA is the most stringent type of device marketing application required by the FDA.

What is the FDA product code for Device, hemostasis, vascular?

The FDA product code for Device, hemostasis, vascular is MGB.

What FDA device class is Device, hemostasis, vascular?

Device, hemostasis, vascular is classified as Class III by the FDA.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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