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FDA 510(k)

ViperCross Support Catheters

K-Number: K212725 · 2021-09-24

ApplicantCardiovascular Systems, Inc.
Decision Date2021-09-24
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ViperCross Support Catheters is the device name listed in this FDA 510(k) record. The listed applicant is Cardiovascular Systems, Inc.. It received FDA 510(k) clearance on 2021-09-24 under 510(k) number K212725. 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 ViperCross Support Catheters?

ViperCross Support Catheters is a medical device that received FDA 510(k) clearance on 2021-09-24. The listed applicant is Cardiovascular Systems, Inc.. The 510(k) number is K212725.

When did ViperCross Support Catheters receive FDA 510(k) clearance?

ViperCross Support Catheters received FDA 510(k) clearance on 2021-09-24, under 510(k) number K212725.

Who is the listed applicant for ViperCross Support Catheters?

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

What is the FDA product code for ViperCross Support Catheters?

The FDA product code for ViperCross Support Catheters is DQY.

Other records listing Cardiovascular Systems, 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.

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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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