510(k) K120738
K120738 is an FDA 510(k) premarket notification submitted by Ostial Corporation for the device "FLASH PTA BALLOON DILATATION CATHETER-4.0X14MMX135CM". The FDA issued a decision of Substantially Equivalent on March 29, 2012. The device falls under product code LIT (Catheter, Angioplasty, Peripheral, Transluminal), a Class II device regulated under 21 CFR 870.1250. Ostial Corporation has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 29, 2012
- Date Received
- March 12, 2012
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Angioplasty, Peripheral, Transluminal
- Device Class
- Class II
- Regulation Number
- 870.1250
- Review Panel
- CV
- Submission Type