REBAR MICRO CATHETER: REBAR-18 [2.3F], 110 CM, 130 CM, 153 CM, SINGLE MARKER BAND AND 153 CM, DUAL MARKER BAND— 510(k) K001966

Substantially Equivalent

Micro Therapeutics, Inc.

FDA 510(k) clearance K001966 for REBAR MICRO CATHETER: REBAR-18 [2.3F], 110 CM, 130 CM, 153 CM, SINGLE MARKER BAND AND 153 CM, DUAL MARKER BAND, Substantially Equivalent on 2000-07-20. Applicant: Micro Therapeutics, Inc..

Clearance details

Applicant: Micro Therapeutics, Inc.
Product code: Code KRA
Advisory panel: Cardiovascular
Date received: 2000-06-28
Decision date: 2000-07-20
Decision: Substantially Equivalent
Clearance type: Special
Location: Irvine, CA, US

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Adverse events under product code KRA

product code KRA

Death: 234
Injury: 1,029
Malfunction: 3,012
Other: 2
Total: 4,277

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.