FDA 510(k)

TITAN MICRO CATHETER, MODEL 105-5074-153; HD INJECTOR, MODEL 103-0305

K-Number: K022003 · 2002-09-13

Decision Date2002-09-13

Product CodeDYB

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

TITAN MICRO CATHETER, MODEL 105-5074-153; HD INJECTOR, MODEL 103-0305 is the device name listed in this FDA 510(k) record. The listed applicant is Micro Therapeutics, Inc.. It received FDA 510(k) clearance on 2002-09-13 under 510(k) number K022003. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TITAN MICRO CATHETER, MODEL 105-5074-153; HD INJECTOR, MODEL 103-0305?

TITAN MICRO CATHETER, MODEL 105-5074-153; HD INJECTOR, MODEL 103-0305 is a medical device that received FDA 510(k) clearance on 2002-09-13. The listed applicant is Micro Therapeutics, Inc.. The 510(k) number is K022003.

When did TITAN MICRO CATHETER, MODEL 105-5074-153; HD INJECTOR, MODEL 103-0305 receive FDA 510(k) clearance?

TITAN MICRO CATHETER, MODEL 105-5074-153; HD INJECTOR, MODEL 103-0305 received FDA 510(k) clearance on 2002-09-13, under 510(k) number K022003.

Who is the listed applicant for TITAN MICRO CATHETER, MODEL 105-5074-153; HD INJECTOR, MODEL 103-0305?

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

What is the FDA product code for TITAN MICRO CATHETER, MODEL 105-5074-153; HD INJECTOR, MODEL 103-0305?

The FDA product code for TITAN MICRO CATHETER, MODEL 105-5074-153; HD INJECTOR, MODEL 103-0305 is DYB.

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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.