510(k) K101047
K101047 is an FDA 510(k) premarket notification submitted by Hotspur Technologies for the device "PTA-DUO PTA BALLOON CATHETER". The FDA issued a decision of Substantially Equivalent on July 13, 2010. The device falls under product code LIT (Catheter, Angioplasty, Peripheral, Transluminal), a Class II device regulated under 21 CFR 870.1250. Hotspur Technologies has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 13, 2010
- Date Received
- April 14, 2010
- Clearance Type
- Traditional
- 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