FDA-Device2025-01-29Class II

Microvention, Headway" 17 Advanced Straight Microcatheter with Hydrophilic Coating, REF: MC172150SX-CN, Sterile R, Rx Only, Lot# 0000629846

MICROVENTION INC.
Hazard

Sterility assurance; microcatheter inner packaging may contain incomplete seal.

Sold states
US: None OUS: China
Affected count
107 units
Manufactured in
35 Enterprise, Aliso Viejo, CA, United States
Products
Microvention, Headway" 17 Advanced Straight Microcatheter with Hydrophilic Coating, REF: MC172150SX-CN, Sterile R, Rx Only, Lot# 0000629846

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0990-2025

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