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FDA 510(k)

CONTRAST CONSERVATION SYSTEM

K-Number: K131478 · 2013-08-15

ApplicantOsprey Medical, Inc.
Decision Date2013-08-15
Product CodeDXT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CONTRAST CONSERVATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Osprey Medical, Inc.. It received FDA 510(k) clearance on 2013-08-15 under 510(k) number K131478. The device is classified under product code DXT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CONTRAST CONSERVATION SYSTEM?

CONTRAST CONSERVATION SYSTEM is a medical device that received FDA 510(k) clearance on 2013-08-15. The listed applicant is Osprey Medical, Inc.. The 510(k) number is K131478.

When did CONTRAST CONSERVATION SYSTEM receive FDA 510(k) clearance?

CONTRAST CONSERVATION SYSTEM received FDA 510(k) clearance on 2013-08-15, under 510(k) number K131478.

Who is the listed applicant for CONTRAST CONSERVATION SYSTEM?

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

What is the FDA product code for CONTRAST CONSERVATION SYSTEM?

The FDA product code for CONTRAST CONSERVATION SYSTEM is DXT.

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Other records listing Osprey Medical, Inc. as applicant

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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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