510(k) K130293
K130293 is an FDA 510(k) premarket notification submitted by Cook, Inc. for the device "ADVANCE 18LP LOW PROFILE PTA BALLOON DILATATION CATHETER". The FDA issued a decision of Substantially Equivalent on May 31, 2013. The device falls under product code LIT (Catheter, Angioplasty, Peripheral, Transluminal), a Class II device regulated under 21 CFR 870.1250. Cook, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 31, 2013
- Date Received
- February 6, 2013
- 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