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FDA 510(k)

PG Pro Microcatheter

K-Number: K192625 · 2019-11-21

ApplicantMicroVention, Inc. A TERUMO Group Company
Decision Date2019-11-21
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PG Pro Microcatheter is the device name listed in this FDA 510(k) record. The listed applicant is MicroVention, Inc. A TERUMO Group Company. It received FDA 510(k) clearance on 2019-11-21 under 510(k) number K192625. 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 PG Pro Microcatheter?

PG Pro Microcatheter is a medical device that received FDA 510(k) clearance on 2019-11-21. The listed applicant is MicroVention, Inc. A TERUMO Group Company. The 510(k) number is K192625.

When did PG Pro Microcatheter receive FDA 510(k) clearance?

PG Pro Microcatheter received FDA 510(k) clearance on 2019-11-21, under 510(k) number K192625.

Who is the listed applicant for PG Pro Microcatheter?

The FDA 510(k) record lists MicroVention, Inc. A TERUMO Group Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PG Pro Microcatheter?

The FDA product code for PG Pro Microcatheter is DQY.

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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