EQUINOX OCCULSION BALLOON SYSTEM MODEL # 104-4015, 104-4018, 104-4021, 104-4023, 104-4026

K010162 · Micro Therapeutics, Inc. · MJN · May 18, 2001 · Cardiovascular

Device Facts

Record IDK010162
Device NameEQUINOX OCCULSION BALLOON SYSTEM MODEL # 104-4015, 104-4018, 104-4021, 104-4023, 104-4026
ApplicantMicro Therapeutics, Inc.
Product CodeMJN · Cardiovascular
Decision DateMay 18, 2001
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 870.4450
Device ClassClass 2

Regulatory Classification

Identification

A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.

Innolitics
510(k) Summary
Decision Summary
Classification Order
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