The following data is part of a premarket notification filed by Xtrak Medical Inc. with the FDA for Xtd Thrombectomy Catheter, Xx Cm.
| Device ID | K021641 |
| 510k Number | K021641 |
| Device Name: | XTD THROMBECTOMY CATHETER, XX CM |
| Classification | Catheter, Embolectomy |
| 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 | DXE |
| CFR Regulation Number | 870.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-05-20 |
| Decision Date | 2002-07-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15711055004333 | K021641 | 000 |