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FDA 510(k)

POLYCATH-H CATHETER

K-Number: K854308 · 1986-04-07

ApplicantAbbott Laboratories
Decision Date1986-04-07
Product CodeFOZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

POLYCATH-H CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1986-04-07 under 510(k) number K854308. The device is classified under product code FOZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POLYCATH-H CATHETER?

POLYCATH-H CATHETER is a medical device that received FDA 510(k) clearance on 1986-04-07. The listed applicant is Abbott Laboratories. The 510(k) number is K854308.

When did POLYCATH-H CATHETER receive FDA 510(k) clearance?

POLYCATH-H CATHETER received FDA 510(k) clearance on 1986-04-07, under 510(k) number K854308.

Who is the listed applicant for POLYCATH-H CATHETER?

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

What is the FDA product code for POLYCATH-H CATHETER?

The FDA product code for POLYCATH-H CATHETER is FOZ.

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Related Devices (Code: FOZ)

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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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