Balloon Dilatation Catheter
- UID
- IMP/MD/2019/000346_16eb53f14e746dc332d80db12a830d7a_375ce1726beefba7b96b91cb7b304aad
- Device class
- Class C
- Brand name
- EZDilate-Fixed Wire
- License holder
- Olympus Medical Systems India Pvt. Ltd
- Approving authority
- CDSCO
- Product information
- The EZDilate 3-Stage Balloon Dilatation Catheters are indicated for use in adult and adolescent (EZDilate-Fixed Wire) populations to endoscopically dilate strictures of the alimentary tract. It is also indicated in adults for endoscopic dilatation of the Sphincter of Oddi with or without prior sphincterotomy.
Balloon Dilatation Catheter is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000346_16eb53f14e746dc332d80db12a830d7a_375ce1726beefba7b96b91cb7b304aad. This device is marketed under the brand name EZDilate-Fixed Wire. The license holder is Olympus Medical Systems India Pvt. Ltd, and it is classified as Device Class Class C. The approving authority is CDSCO.
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