FDA 510(k)

Primum Hydrophilic Guiding Catheter

K-Number: K250972 · 2025-06-29

Decision Date2025-06-29

Product CodeDQY

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Primum Hydrophilic Guiding Catheter is a medical device manufactured by Pendracare. It received FDA 510(k) clearance on 2025-06-29 under approval number K250972. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Primum Hydrophilic Guiding Catheter?

Primum Hydrophilic Guiding Catheter is a medical device that received FDA 510(k) clearance on 2025-06-29. It is manufactured by Pendracare. The 510(k) number is K250972.

When was Primum Hydrophilic Guiding Catheter approved by the FDA?

Primum Hydrophilic Guiding Catheter received FDA 510(k) clearance on 2025-06-29, under approval number K250972.

What company makes Primum Hydrophilic Guiding Catheter?

Primum Hydrophilic Guiding Catheter is manufactured by Pendracare.

What is the FDA product code for Primum Hydrophilic Guiding Catheter?

The FDA product code for Primum Hydrophilic Guiding Catheter is DQY.

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Related Devices (Code: DQY)

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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.