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FDA 510(k)

STEALTH DILATION CATHETER SYSTEM (MODIFIED)

K-Number: K915895 · 1992-06-04

ApplicantTarget Therapeutics
Decision Date1992-06-04
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

STEALTH DILATION CATHETER SYSTEM (MODIFIED) is the device name listed in this FDA 510(k) record. The listed applicant is Target Therapeutics. It received FDA 510(k) clearance on 1992-06-04 under 510(k) number K915895. 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 DILATION CATHETER SYSTEM (MODIFIED)?

STEALTH DILATION CATHETER SYSTEM (MODIFIED) is a medical device that received FDA 510(k) clearance on 1992-06-04. The listed applicant is Target Therapeutics. The 510(k) number is K915895.

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

STEALTH DILATION CATHETER SYSTEM (MODIFIED) received FDA 510(k) clearance on 1992-06-04, under 510(k) number K915895.

Who is the listed applicant for STEALTH DILATION CATHETER SYSTEM (MODIFIED)?

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 DILATION CATHETER SYSTEM (MODIFIED)?

The FDA product code for STEALTH DILATION CATHETER SYSTEM (MODIFIED) 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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