| Proprietary Device Name: | ACUCISE |
| Common Generic Device Name: | LOW PRESSURE TAMPONADE BALLOON CATHETER |
| Classification Name: | DILATOR, CATHETER, URETERAL |
| FDA Regulation Number: | 876.5470 |
| Product Differentiation: | Applied Access Sheath The Applied Access Sheath facilitates endourologic procedures by gently dilating the ureter and providing a continuous working channel. Gentle dilation • Tapered dilator gently traverses ureteral orifice • Replaces expensive balloon dilators • Unique locking mechanism ensures simultaneous advancement of the dilator and sheath for added security Less trauma • Protects the ureter during repeated instrument exchanges • SL-6 Hydrophilic Coating facilitates advancement Continual access • Reduces procedural time • Protects scopes and delicate instruments from costly repairs |
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