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FDA 510(k)

REEKROSS FAMILY OR OTW PTA CATHETERS

K-Number: K083596 · 2009-03-02

ApplicantClearStream Technologies , Ltd.
Decision Date2009-03-02
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

REEKROSS FAMILY OR OTW PTA CATHETERS is the device name listed in this FDA 510(k) record. The listed applicant is ClearStream Technologies , Ltd.. It received FDA 510(k) clearance on 2009-03-02 under 510(k) number K083596. 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 REEKROSS FAMILY OR OTW PTA CATHETERS?

REEKROSS FAMILY OR OTW PTA CATHETERS is a medical device that received FDA 510(k) clearance on 2009-03-02. The listed applicant is ClearStream Technologies , Ltd.. The 510(k) number is K083596.

When did REEKROSS FAMILY OR OTW PTA CATHETERS receive FDA 510(k) clearance?

REEKROSS FAMILY OR OTW PTA CATHETERS received FDA 510(k) clearance on 2009-03-02, under 510(k) number K083596.

Who is the listed applicant for REEKROSS FAMILY OR OTW PTA CATHETERS?

The FDA 510(k) record lists ClearStream Technologies , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for REEKROSS FAMILY OR OTW PTA CATHETERS?

The FDA product code for REEKROSS FAMILY OR OTW PTA CATHETERS is DQY.

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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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