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FDA 510(k)

THROMBOLYTIC BRUSH CATHETER, OVER THE WIRE (OTW)

K-Number: K973669 · 1998-02-06

ApplicantMicro Therapeutics, Inc.
Decision Date1998-02-06
Product CodeMCW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

THROMBOLYTIC BRUSH CATHETER, OVER THE WIRE (OTW) 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 1998-02-06 under 510(k) number K973669. The device is classified under product code MCW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THROMBOLYTIC BRUSH CATHETER, OVER THE WIRE (OTW)?

THROMBOLYTIC BRUSH CATHETER, OVER THE WIRE (OTW) is a medical device that received FDA 510(k) clearance on 1998-02-06. The listed applicant is Micro Therapeutics, Inc.. The 510(k) number is K973669.

When did THROMBOLYTIC BRUSH CATHETER, OVER THE WIRE (OTW) receive FDA 510(k) clearance?

THROMBOLYTIC BRUSH CATHETER, OVER THE WIRE (OTW) received FDA 510(k) clearance on 1998-02-06, under 510(k) number K973669.

Who is the listed applicant for THROMBOLYTIC BRUSH CATHETER, OVER THE WIRE (OTW)?

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 THROMBOLYTIC BRUSH CATHETER, OVER THE WIRE (OTW)?

The FDA product code for THROMBOLYTIC BRUSH CATHETER, OVER THE WIRE (OTW) is MCW.

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Related Devices (Code: MCW)

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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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