510(k) K181023
K181023 is an FDA 510(k) premarket notification submitted by Meril Life Sciences Private Limited for the device "Mozec Rx PTCA Balloon Dilatation Catheter, Mozec NC Rx PTCA Balloon Dilatation Catheter". The FDA issued a decision of Substantially Equivalent on May 17, 2018. The device falls under product code LOX (Catheters, Transluminal Coronary Angioplasty, Percutaneous), a Class II device regulated under 21 CFR 870.5100. Meril Life Sciences Private Limited has 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 17, 2018
- Date Received
- Apr 17, 2018
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheters, Transluminal Coronary Angioplasty, Percutaneous
- Device Class
- Class II
- Regulation Number
- 870.5100
- Review Panel
- CV
- Submission Type
- 510(k)
A PTCA catheter is a device that operates on the principle of hydraulic pressurization applied through an inflatable balloon attached to the distal end.