510(k) K100842
K100842 is an FDA 510(k) premarket notification submitted by Hotspur Technologies for the device "PTA-PLUS PTA BALLOON CATHER 5 MM X 4CM, PTA-PLUS PTA BALLOON CATHETER 6MM X 4CM". The FDA issued a decision of Substantially Equivalent on July 12, 2010. The device falls under product code DXE (Catheter, Embolectomy), a Class II device regulated under 21 CFR 870.5150. Hotspur Technologies has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 12, 2010
- Date Received
- March 25, 2010
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Embolectomy
- Device Class
- Class II
- Regulation Number
- 870.5150
- Review Panel
- CV
- Submission Type