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FDA 510(k)

OXYGENATION CATHETER

K-Number: K881881 · 1989-02-17

ApplicantVentech Healthcare Corp., Inc.
Decision Date1989-02-17
Product CodeBTM
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

OXYGENATION CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Ventech Healthcare Corp., Inc.. It received FDA 510(k) clearance on 1989-02-17 under 510(k) number K881881. The device is classified under product code BTM. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OXYGENATION CATHETER?

OXYGENATION CATHETER is a medical device that received FDA 510(k) clearance on 1989-02-17. The listed applicant is Ventech Healthcare Corp., Inc.. The 510(k) number is K881881.

When did OXYGENATION CATHETER receive FDA 510(k) clearance?

OXYGENATION CATHETER received FDA 510(k) clearance on 1989-02-17, under 510(k) number K881881.

Who is the listed applicant for OXYGENATION CATHETER?

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

What is the FDA product code for OXYGENATION CATHETER?

The FDA product code for OXYGENATION CATHETER is BTM.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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