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FDA 510(k)

ViperCath XC Peripheral Exchange Catheter

K-Number: K183000 · 2018-12-29

ApplicantCardiovascular Systems, Inc.
Decision Date2018-12-29
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ViperCath XC Peripheral Exchange Catheter 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 2018-12-29 under 510(k) number K183000. 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 ViperCath XC Peripheral Exchange Catheter?

ViperCath XC Peripheral Exchange Catheter is a medical device that received FDA 510(k) clearance on 2018-12-29. The listed applicant is Cardiovascular Systems, Inc.. The 510(k) number is K183000.

When did ViperCath XC Peripheral Exchange Catheter receive FDA 510(k) clearance?

ViperCath XC Peripheral Exchange Catheter received FDA 510(k) clearance on 2018-12-29, under 510(k) number K183000.

Who is the listed applicant for ViperCath XC Peripheral Exchange Catheter?

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 ViperCath XC Peripheral Exchange Catheter?

The FDA product code for ViperCath XC Peripheral Exchange Catheter 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.

PMA P130005CATHETER, CORONARY, ATHERECTOMYK220109DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeable Series, Stealth 360 Peripheral Orbital Atherectomy SystemK212725ViperCross Support CathetersK210586Diamonback 360 Peripheral Orbital Atherectomy System, Diamondback 360 Stealth Orbital Atherectomy systemK211240ViperCross Support CathetersK211251ViperCath XC Peripheral Exchange Catheter

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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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