Arch Catheter, LLC
Gatekeeper Balloon Catheter
SKU K192786UPC MJN
In Stock
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IIFDA 510(k) Cleared (K192786)
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Free shipping on orders over $99 · 30-day returns
Arch Catheter, LLC
Free shipping on orders over $99 · 30-day returns
Gatekeeper Balloon Catheter is an FDA 510(k)-cleared medical device (K192786) manufactured by Arch Catheter, LLC. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 24, 2020. Regulation: 8.
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