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FDA 510(k)

PULMOCATH INTRABRONCHIAL CATHETER

K-Number: K901615 · 1992-11-27

ApplicantOmnitron Intl., Inc.
Decision Date1992-11-27
Product CodeJAQ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PULMOCATH INTRABRONCHIAL CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Omnitron Intl., Inc.. It received FDA 510(k) clearance on 1992-11-27 under 510(k) number K901615. The device is classified under product code JAQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PULMOCATH INTRABRONCHIAL CATHETER?

PULMOCATH INTRABRONCHIAL CATHETER is a medical device that received FDA 510(k) clearance on 1992-11-27. The listed applicant is Omnitron Intl., Inc.. The 510(k) number is K901615.

When did PULMOCATH INTRABRONCHIAL CATHETER receive FDA 510(k) clearance?

PULMOCATH INTRABRONCHIAL CATHETER received FDA 510(k) clearance on 1992-11-27, under 510(k) number K901615.

Who is the listed applicant for PULMOCATH INTRABRONCHIAL CATHETER?

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

What is the FDA product code for PULMOCATH INTRABRONCHIAL CATHETER?

The FDA product code for PULMOCATH INTRABRONCHIAL CATHETER is JAQ.

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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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