FDA 510(k), K111738, CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) GUIDE WIRE (0.014 AND 0.018)

Contents: Correspondence, Substantially Equivalence Mapping, 510k Summary, 510K Screening Checklist, Device Comparison Table, Third Party Review Checklist, Labeling, Indications for Use, Instructions for Use, Extent of Standard Conformance Summary Report Table

510(K) Number: K111738
Device Name: CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) GUIDE WIRE (0.014 AND 0.018)
Manufacturer: SHIVA ARDAKAMI
Device Classification Name: Catheter, Percutaneous
Regulation Number: DQY
Classification Product Code: 06/21/2011
Date Received: 12/14/2011
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular

144 pages (701 of 845 original pages are fully redacted)