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The ProtekDilate Vascular Access Kits are intended for single use by a trained physician to assist in vessel cannulation.

The subject device ProtekDilate Vascular Access Kits are intended for single use by a trained physician to assist in vessel cannulation. The subject device kits are comprised of eight (8) vascular dilators with diameters of 8/10, 14, 16, 18, 22, 26, 28, and 30 Fr. The dilators are designed to accept 0.035" and 0.038" guidewires and consists of hubs comprised of ABS. Additional kit components include a #11 scalpel, 18 GA Seldinger type echogenic introducer needle, 10 cc syringe, and two 0.035" or 0.038" guidewires. All kit components, including the 8/10 Fr dilator (8/10 Two Stage Dilator, K162389), are off-the-shelf with the exception of the 14-30 Fr dilators, which will be manufactured by Sorin Group Italia S.R.L..

The ProtekDilate Vascular Access Kits are sterile, non-pyrogenic devices for single use only, and are not to be re-sterilized by the user.

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