FDA-Device2015-06-17Class III

RELIEVA FLEX Sinus Guide Catheter F-70. Catalog number GC070RF. Product Usage - Sinus Catheter - Intended to provide a means to access the sinus space for diagnostic and therapeutic procedures. .

Acclarent, Inc.
Hazard

Acclarent determined that one single RELIEVA FLEX Sinus Guide Catheter was distributed past it's expiry date.

Sold states
US in the state of Texas
Affected count
986
Manufactured in
1525B Obrien Dr, N/A, Menlo Park, CA, United States
Products
RELIEVA FLEX Sinus Guide Catheter F-70. Catalog number GC070RF. Product Usage - Sinus Catheter - Intended to provide a means to access the sinus space for diagnostic and therapeutic procedures. .

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1740-2015

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