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FDA 510(k)

XableCath Support Catheter Product Family

K-Number: K180986 · 2018-05-15

ApplicantXablecath, Inc.
Decision Date2018-05-15
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

XableCath Support Catheter Product Family is the device name listed in this FDA 510(k) record. The listed applicant is Xablecath, Inc.. It received FDA 510(k) clearance on 2018-05-15 under 510(k) number K180986. 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 XableCath Support Catheter Product Family?

XableCath Support Catheter Product Family is a medical device that received FDA 510(k) clearance on 2018-05-15. The listed applicant is Xablecath, Inc.. The 510(k) number is K180986.

When did XableCath Support Catheter Product Family receive FDA 510(k) clearance?

XableCath Support Catheter Product Family received FDA 510(k) clearance on 2018-05-15, under 510(k) number K180986.

Who is the listed applicant for XableCath Support Catheter Product Family?

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

What is the FDA product code for XableCath Support Catheter Product Family?

The FDA product code for XableCath Support Catheter Product Family is DQY.

Other records listing Xablecath, Inc. 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.

K183357XableCath Crossing CatheterK170041XableCath Support Catheter

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

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

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