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FDA 510(k)

M-CATH Microcatheter

K-Number: K171176 · 2017-09-15

ApplicantAcrostak (Schweiz) AG
Decision Date2017-09-15
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

M-CATH Microcatheter is the device name listed in this FDA 510(k) record. The listed applicant is Acrostak (Schweiz) AG. It received FDA 510(k) clearance on 2017-09-15 under 510(k) number K171176. 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 M-CATH Microcatheter?

M-CATH Microcatheter is a medical device that received FDA 510(k) clearance on 2017-09-15. The listed applicant is Acrostak (Schweiz) AG. The 510(k) number is K171176.

When did M-CATH Microcatheter receive FDA 510(k) clearance?

M-CATH Microcatheter received FDA 510(k) clearance on 2017-09-15, under 510(k) number K171176.

Who is the listed applicant for M-CATH Microcatheter?

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

What is the FDA product code for M-CATH Microcatheter?

The FDA product code for M-CATH 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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