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FDA 510(k)

SPIRALGOLD & SPIRALOXY HOLLOW FIBER OXYGENATORS

K-Number: K951247 · 1995-11-02

ApplicantBaxter Healthcare Corp
Decision Date1995-11-02
Product CodeDTZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SPIRALGOLD & SPIRALOXY HOLLOW FIBER OXYGENATORS is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corp. It received FDA 510(k) clearance on 1995-11-02 under 510(k) number K951247. The device is classified under product code DTZ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPIRALGOLD & SPIRALOXY HOLLOW FIBER OXYGENATORS?

SPIRALGOLD & SPIRALOXY HOLLOW FIBER OXYGENATORS is a medical device that received FDA 510(k) clearance on 1995-11-02. The listed applicant is Baxter Healthcare Corp. The 510(k) number is K951247.

When did SPIRALGOLD & SPIRALOXY HOLLOW FIBER OXYGENATORS receive FDA 510(k) clearance?

SPIRALGOLD & SPIRALOXY HOLLOW FIBER OXYGENATORS received FDA 510(k) clearance on 1995-11-02, under 510(k) number K951247.

Who is the listed applicant for SPIRALGOLD & SPIRALOXY HOLLOW FIBER OXYGENATORS?

The FDA 510(k) record lists Baxter Healthcare Corp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPIRALGOLD & SPIRALOXY HOLLOW FIBER OXYGENATORS?

The FDA product code for SPIRALGOLD & SPIRALOXY HOLLOW FIBER OXYGENATORS is DTZ.

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Related Devices (Code: DTZ)

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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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