FDA-Device2025-03-05Class II
Socrates 38 Aspiration Catheter 127 cm length REF SC038-127-001 The Socrates Aspiration System with a compatible suction pump is intended for use in the revascularization of patients with acute ischemic stroke
Scientia Vascular, Inc.
Hazard
Due to manufacturing non-conformance that resulted in channels in the seal on the packaging pouch. As a result, this could potential create a breach in the sterile barrier.
Sold states
U..S. Nationwide distribution in the states of AL, AZ, FL, GA, HI, IL, IN, KS, MN, NC, NJ, NY, PA, SD, TX, VA, WI and WV.
Affected count
120 devices
Manufactured in
2460 S 3270 W, N/A, West Valley City, UT, United States
Products
Socrates 38 Aspiration Catheter 127 cm length REF SC038-127-001 The Socrates Aspiration System with a compatible suction pump is intended for use in the revascularization of patients with acute ischemic stroke
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1234-2025Don't want to check this manually?
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