Aspiration Catheter, Aspiration Tubing and Select Catheter (Indigo System Lightning Flash ) - India CDSCO Medical Device Registration

Aspiration Catheter, Aspiration Tubing and Select Catheter (Indigo System Lightning Flash ) is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2022/000227_424f9d7316596fba8e20e80f8c8a9f92_60ca786253306060a9ec271c0f4616c4. This device is marketed under the brand name Neuron MAX 6F Long Sheath. The license holder is M/S ASIA ACTUAL INDIA (OPC) PVT. LTD., and it is classified as Device Class Class D. The approving authority is CDSCO.

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CDSCO Registered

Class Class D

Aspiration Catheter, Aspiration Tubing and Select Catheter (Indigo System Lightning Flash )

UID: IMP/MD/2022/000227_424f9d7316596fba8e20e80f8c8a9f92_60ca786253306060a9ec271c0f4616c4

Brand Name

Neuron MAX 6F Long Sheath

License Holder

M/S ASIA ACTUAL INDIA (OPC) PVT. LTD.

Device Class

Class D

Approving Authority

CDSCO

Product Information

INDIGO Aspiration Catheters As part of the Indigo Aspiration System, the Indigo Aspiration Catheters are indicated for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems, and for the treatment of pulmonary embolism. Lightning Flash Aspiration Tubing As part of the INDIGO Aspiration System, the INDIGO Sterile Aspiration Tubing is indicated to connect the INDIGO Aspiration Catheters to the Penumbra Aspiration Pump. Select Catheter Select Catheter is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature