510(k) K141025
K141025 is an FDA 510(k) premarket notification submitted by Brosmed Medical for the device "ARTIMES BALLOON DILATATION CATHETER". The FDA issued a decision of Substantially Equivalent on Sep 12, 2014. The device falls under product code LOX (Catheters, Transluminal Coronary Angioplasty, Percutaneous), a Class II device regulated under 21 CFR 870.5100. Brosmed Medical has 1 other 510(k) clearance on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 12, 2014
- Date Received
- Apr 21, 2014
- Clearance Type
- Traditional
- 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.