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FDA 510(k)

VIPERSPHERE PTA BALLOON CATHETER

K-Number: K083139 · 2008-11-25

ApplicantCardiovascular Systems, Inc.
Decision Date2008-11-25
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VIPERSPHERE PTA BALLOON 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 2008-11-25 under 510(k) number K083139. 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 VIPERSPHERE PTA BALLOON CATHETER?

VIPERSPHERE PTA BALLOON CATHETER is a medical device that received FDA 510(k) clearance on 2008-11-25. The listed applicant is Cardiovascular Systems, Inc.. The 510(k) number is K083139.

When did VIPERSPHERE PTA BALLOON CATHETER receive FDA 510(k) clearance?

VIPERSPHERE PTA BALLOON CATHETER received FDA 510(k) clearance on 2008-11-25, under 510(k) number K083139.

Who is the listed applicant for VIPERSPHERE PTA BALLOON 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 VIPERSPHERE PTA BALLOON CATHETER?

The FDA product code for VIPERSPHERE PTA BALLOON CATHETER is DQY.

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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.

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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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