The following data is part of a premarket notification filed by Kaneka Pharma America Llc with the FDA for Kaneka Pharma America Xpress-way Rx.
| Device ID | K101839 |
| 510k Number | K101839 |
| Device Name: | KANEKA PHARMA AMERICA XPRESS-WAY RX |
| Classification | Catheter, Embolectomy |
| Applicant | KANEKA PHARMA AMERICA LLC 5 WENTWORTH DRIVE Hudson, NH 03051 |
| Contact | Raymond Kelly |
| Correspondent | Raymond Kelly KANEKA PHARMA AMERICA LLC 5 WENTWORTH DRIVE Hudson, NH 03051 |
| Product Code | DXE |
| CFR Regulation Number | 870.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-07-01 |
| Decision Date | 2010-10-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04540778133983 | K101839 | 000 |
| 04540778133976 | K101839 | 000 |