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FDA 510(k)

Primum Hydrophilic Guiding Catheter

K-Number: K250972 · 2025-06-29

ApplicantPendracare
Decision Date2025-06-29
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Primum Hydrophilic Guiding Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Pendracare. It received FDA 510(k) clearance on 2025-06-29 under 510(k) 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. The listed applicant is Pendracare. The 510(k) number is K250972.

When did Primum Hydrophilic Guiding Catheter receive FDA 510(k) clearance?

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

Who is the listed applicant for Primum Hydrophilic Guiding Catheter?

The FDA 510(k) record lists Pendracare as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Pendracare as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261242SimplGuide

Related Devices (Code: DQY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260559NHanceITIMDS Operation B.V.K262392APRO 35 Swift CatheterAlembic, LLCK262240SSPC NXT Delivery CatheterCenterPoint Systems, LLCK261766CPS Locator 3D Plus Delivery CatheterCenterPoint Systems, LLCK261825Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP CatheterAbbottK261631Amplatzer TorqVue Exchange SystemAbbott Medical

Official Source

View on FDA Database →

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

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