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FDA 510(k)

SPIRTOS COAXIAL CATHETER SET

K-Number: K896524 · 1990-09-05

ApplicantCook Ob/Gyn
Decision Date1990-09-05
Product CodeHET
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

SPIRTOS COAXIAL CATHETER SET is the device name listed in this FDA 510(k) record. The listed applicant is Cook Ob/Gyn. It received FDA 510(k) clearance on 1990-09-05 under 510(k) number K896524. The device is classified under product code HET. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPIRTOS COAXIAL CATHETER SET?

SPIRTOS COAXIAL CATHETER SET is a medical device that received FDA 510(k) clearance on 1990-09-05. The listed applicant is Cook Ob/Gyn. The 510(k) number is K896524.

When did SPIRTOS COAXIAL CATHETER SET receive FDA 510(k) clearance?

SPIRTOS COAXIAL CATHETER SET received FDA 510(k) clearance on 1990-09-05, under 510(k) number K896524.

Who is the listed applicant for SPIRTOS COAXIAL CATHETER SET?

The FDA 510(k) record lists Cook Ob/Gyn as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPIRTOS COAXIAL CATHETER SET?

The FDA product code for SPIRTOS COAXIAL CATHETER SET is HET.

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Other records listing Cook Ob/Gyn 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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