The following data is part of a premarket notification filed by Xtrak Medical Inc. with the FDA for Xtd Thrombectomy Catheter, Xx Cm, Model# Ct000500x; Xtd Control Console, Model # Ct0006001; Xtd Collection Bottle, Model.
| Device ID | K013473 |
| 510k Number | K013473 |
| Device Name: | XTD THROMBECTOMY CATHETER, XX CM, MODEL# CT000500X; XTD CONTROL CONSOLE, MODEL # CT0006001; XTD COLLECTION BOTTLE, MODEL |
| Classification | Catheter, Peripheral, Atherectomy |
| Applicant | XTRAK MEDICAL INC. 7 TIFFANY TRAIL Hopkinton, MA 01748 |
| Contact | Debbie Iampietro |
| Correspondent | Debbie Iampietro XTRAK MEDICAL INC. 7 TIFFANY TRAIL Hopkinton, MA 01748 |
| Product Code | MCW |
| CFR Regulation Number | 870.4875 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-10-18 |
| Decision Date | 2002-03-06 |
| Summary: | summary |