The following data is part of a premarket notification filed by Impra, Inc. with the FDA for Arterial Embolectomy Catheter.
| Device ID | K900311 |
| 510k Number | K900311 |
| Device Name: | ARTERIAL EMBOLECTOMY CATHETER |
| Classification | Catheter, Embolectomy |
| Applicant | IMPRA, INC. 1625 WEST 3RD ST. P.O. BOX 1740 Tempe, AZ 85281 |
| Contact | Bill Colone |
| Correspondent | Bill Colone IMPRA, INC. 1625 WEST 3RD ST. P.O. BOX 1740 Tempe, AZ 85281 |
| Product Code | DXE |
| CFR Regulation Number | 870.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-01-22 |
| Decision Date | 1990-07-17 |