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FDA 510(k)

POLARCATH PERIPHERAL DILATATION SYSTEM

K-Number: K033622 · 2004-02-10

ApplicantCryo Vascular Systems, Inc.
Decision Date2004-02-10
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

POLARCATH PERIPHERAL DILATATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Cryo Vascular Systems, Inc.. It received FDA 510(k) clearance on 2004-02-10 under 510(k) number K033622. 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 POLARCATH PERIPHERAL DILATATION SYSTEM?

POLARCATH PERIPHERAL DILATATION SYSTEM is a medical device that received FDA 510(k) clearance on 2004-02-10. The listed applicant is Cryo Vascular Systems, Inc.. The 510(k) number is K033622.

When did POLARCATH PERIPHERAL DILATATION SYSTEM receive FDA 510(k) clearance?

POLARCATH PERIPHERAL DILATATION SYSTEM received FDA 510(k) clearance on 2004-02-10, under 510(k) number K033622.

Who is the listed applicant for POLARCATH PERIPHERAL DILATATION SYSTEM?

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

What is the FDA product code for POLARCATH PERIPHERAL DILATATION SYSTEM?

The FDA product code for POLARCATH PERIPHERAL DILATATION SYSTEM is DQY.

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Other records listing Cryo Vascular 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.

K051916POLAR CATH PERIPHERAL DILATATION SYSTEMK042230POLARCATH PERIPHERAL BALLOON CATHETER SYSTEMK042541MODIFICATION TO POLARCATH PERIPHERAL DILATATION SYSTEMK030742POLARCATH PERIPHERAL BALLOON CATHETER SYSTEMK023463CVSI PERIPHERAL BALLOON CATHETER; CVSI CATHETER INFLATION UNITK022061CVSI PERIPHERAL BALLOON CATHETER; CVSI INFLATER

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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.

K262817CrossFAST Integrated Microcatheter Advanced Delivery SystemVantis Vascular, Inc.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 CatheterAbbott

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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