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FDA 510(k)

REBAR MICRO CATHETER: REBAR-18 [2.3F], 110 CM, 130 CM, 153 CM, SINGLE MARKER BAND AND 153 CM, DUAL MARKER BAND

K-Number: K001966 · 2000-07-20

ApplicantMicro Therapeutics, Inc.
Decision Date2000-07-20
Product CodeKRA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

REBAR MICRO CATHETER: REBAR-18 [2.3F], 110 CM, 130 CM, 153 CM, SINGLE MARKER BAND AND 153 CM, DUAL MARKER BAND 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 2000-07-20 under 510(k) number K001966. The device is classified under product code KRA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REBAR MICRO CATHETER: REBAR-18 [2.3F], 110 CM, 130 CM, 153 CM, SINGLE MARKER BAND AND 153 CM, DUAL MARKER BAND?

REBAR MICRO CATHETER: REBAR-18 [2.3F], 110 CM, 130 CM, 153 CM, SINGLE MARKER BAND AND 153 CM, DUAL MARKER BAND is a medical device that received FDA 510(k) clearance on 2000-07-20. The listed applicant is Micro Therapeutics, Inc.. The 510(k) number is K001966.

When did REBAR MICRO CATHETER: REBAR-18 [2.3F], 110 CM, 130 CM, 153 CM, SINGLE MARKER BAND AND 153 CM, DUAL MARKER BAND receive FDA 510(k) clearance?

REBAR MICRO CATHETER: REBAR-18 [2.3F], 110 CM, 130 CM, 153 CM, SINGLE MARKER BAND AND 153 CM, DUAL MARKER BAND received FDA 510(k) clearance on 2000-07-20, under 510(k) number K001966.

Who is the listed applicant for REBAR MICRO CATHETER: REBAR-18 [2.3F], 110 CM, 130 CM, 153 CM, SINGLE MARKER BAND AND 153 CM, DUAL MARKER BAND?

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 REBAR MICRO CATHETER: REBAR-18 [2.3F], 110 CM, 130 CM, 153 CM, SINGLE MARKER BAND AND 153 CM, DUAL MARKER BAND?

The FDA product code for REBAR MICRO CATHETER: REBAR-18 [2.3F], 110 CM, 130 CM, 153 CM, SINGLE MARKER BAND AND 153 CM, DUAL MARKER BAND is KRA.

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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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