HYPERGLIDE OCCLUSION BALLOON SYSTEM, MODEL 104-4118, 104-4121, 104-4129, 104-4126, 104-4115, 104-4123

K011526 · Micro Therapeutics, Inc. · MJN · Jun 14, 2001 · Cardiovascular

Device Facts

Record IDK011526
Device NameHYPERGLIDE OCCLUSION BALLOON SYSTEM, MODEL 104-4118, 104-4121, 104-4129, 104-4126, 104-4115, 104-4123
ApplicantMicro Therapeutics, Inc.
Product CodeMJN · Cardiovascular
Decision DateJun 14, 2001
DecisionSESE
Submission TypeSpecial
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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