The following data is part of a premarket notification filed by Xtrak Medical Inc. with the FDA for Xtrak Support Catheter.
| Device ID | K032660 |
| 510k Number | K032660 |
| Device Name: | XTRAK SUPPORT CATHETER |
| Classification | Catheter, Percutaneous |
| 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 | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-08-28 |
| Decision Date | 2003-10-29 |
| Summary: | summary |