The following data is part of a premarket notification filed by Kaneka Pharma America Llc with the FDA for Xpressway Rx Catheter (6f Ld-verison).
| Device ID | K121301 |
| 510k Number | K121301 |
| Device Name: | XPRESSWAY RX CATHETER (6F LD-VERISON) |
| Classification | Catheter, Embolectomy |
| Applicant | KANEKA PHARMA AMERICA LLC 546 FIFTH AVE., 21ST FLOOR New York, NY 10036 |
| Contact | Joseph Depaolo |
| Correspondent | Joseph Depaolo KANEKA PHARMA AMERICA LLC 546 FIFTH AVE., 21ST FLOOR New York, NY 10036 |
| Product Code | DXE |
| CFR Regulation Number | 870.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-05-01 |
| Decision Date | 2012-07-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04540778139602 | K121301 | 000 |