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FDA 510(k)

QuikPass Catheter

K-Number: K214106 · 2022-01-28

ApplicantTraverse Vascular, Inc.
Decision Date2022-01-28
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

QuikPass Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Traverse Vascular, Inc.. It received FDA 510(k) clearance on 2022-01-28 under 510(k) number K214106. 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 QuikPass Catheter?

QuikPass Catheter is a medical device that received FDA 510(k) clearance on 2022-01-28. The listed applicant is Traverse Vascular, Inc.. The 510(k) number is K214106.

When did QuikPass Catheter receive FDA 510(k) clearance?

QuikPass Catheter received FDA 510(k) clearance on 2022-01-28, under 510(k) number K214106.

Who is the listed applicant for QuikPass Catheter?

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

What is the FDA product code for QuikPass Catheter?

The FDA product code for QuikPass 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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