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FDA 510(k)

STEALTH CATHETER SYSTEM

K-Number: K911089 · 1991-05-29

ApplicantTarget Therapeutics
Decision Date1991-05-29
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

STEALTH CATHETER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Target Therapeutics. It received FDA 510(k) clearance on 1991-05-29 under 510(k) number K911089. The device is classified under product code LIT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STEALTH CATHETER SYSTEM?

STEALTH CATHETER SYSTEM is a medical device that received FDA 510(k) clearance on 1991-05-29. The listed applicant is Target Therapeutics. The 510(k) number is K911089.

When did STEALTH CATHETER SYSTEM receive FDA 510(k) clearance?

STEALTH CATHETER SYSTEM received FDA 510(k) clearance on 1991-05-29, under 510(k) number K911089.

Who is the listed applicant for STEALTH CATHETER SYSTEM?

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

What is the FDA product code for STEALTH CATHETER SYSTEM?

The FDA product code for STEALTH CATHETER SYSTEM is LIT.

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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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