CDSCO UID MFG/MD/2019/000230_8c16193f318996f61b1cd66ff09a6708_091dec2fe1dd51c0d1d70e9196e06dc3
Temporary Pacemaker Electrode Sterile
Lotus Surgical Pvt Ltd·Device Class Class D·India CDSCO·Brand: Bylatoral Femoral Bypass Surgery Kit
Registration details
- UID
- MFG/MD/2019/000230_8c16193f318996f61b1cd66ff09a6708_091dec2fe1dd51c0d1d70e9196e06dc3
- Device class
- Class D
- Brand name
- Bylatoral Femoral Bypass Surgery Kit
- License holder
- Lotus Surgical Pvt Ltd
- Approving authority
- CDSCO -North Zone, Ghaziabad
- Product information
- Temporary Pacing Wire is indicated for use as a temporary pacing wire to transfer electrical energy along its length between the external pacemaker and the patient’s heart for temporary cardiac pacing and intra-cardial ECG monitoring during and after open-heart surgery, for single use only. Temporary Pacing Wire has one end stripped of insulation for some length, or anchored and conductively crimped to a curved taper point suture needle for facilitating fixation in the myocardium or if anchored; penetration through myocardium and fixation by anchor. Anchor is the stripped of and spread part of the insulation close to the curved needle. The other end of the insulated lead is conductively attached to a straight cutting edge Keith needle which is pushed through the thoracic cavity wall from the interior to the exterior. The Keith needle may be equipped with a special break-off groove. The cutting part of the needle is broken off from the groove, and the stub forms an electrode plug which is connected to conventional pacing and monitoring equipment. The Keith needle is supplied shrouded with plastic tubing.
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About this record
Temporary Pacemaker Electrode Sterile is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2019/000230_8c16193f318996f61b1cd66ff09a6708_091dec2fe1dd51c0d1d70e9196e06dc3. This device is marketed under the brand name Bylatoral Femoral Bypass Surgery Kit. The license holder is Lotus Surgical Pvt Ltd, and it is classified as Device Class Class D. The approving authority is CDSCO -North Zone, Ghaziabad.
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