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FDA 510(k)

Attain Assist CS Access Catheter

K-Number: K171819 · 2018-01-04

ApplicantCreganna Medical Also Doing Business AS Ceganna Tactx Medica
Decision Date2018-01-04
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Attain Assist CS Access Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Creganna Medical Also Doing Business AS Ceganna Tactx Medica. It received FDA 510(k) clearance on 2018-01-04 under 510(k) number K171819. 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 Attain Assist CS Access Catheter?

Attain Assist CS Access Catheter is a medical device that received FDA 510(k) clearance on 2018-01-04. The listed applicant is Creganna Medical Also Doing Business AS Ceganna Tactx Medica. The 510(k) number is K171819.

When did Attain Assist CS Access Catheter receive FDA 510(k) clearance?

Attain Assist CS Access Catheter received FDA 510(k) clearance on 2018-01-04, under 510(k) number K171819.

Who is the listed applicant for Attain Assist CS Access Catheter?

The FDA 510(k) record lists Creganna Medical Also Doing Business AS Ceganna Tactx Medica as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Attain Assist CS Access Catheter?

The FDA product code for Attain Assist CS Access Catheter 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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