510(k) K130397
K130397 is an FDA 510(k) premarket notification submitted by Hotspur Technologies for the device "ARROW GPSCATH BALLOON DILATATION CATHETER". The FDA issued a decision of Substantially Equivalent on June 20, 2013. 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
- June 20, 2013
- Date Received
- February 19, 2013
- 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