The following data is part of a premarket notification filed by Impra, Inc. with the FDA for Impra Dual Lumen Subclavian Catheter.
| Device ID | K872163 |
| 510k Number | K872163 |
| Device Name: | IMPRA DUAL LUMEN SUBCLAVIAN CATHETER |
| Classification | Catheter, Percutaneous |
| Applicant | IMPRA, INC. 1625 WEST 3RD ST. P.O. BOX 1740 Tempe, AZ 85281 |
| Contact | James M Mchaney |
| Correspondent | James M Mchaney IMPRA, INC. 1625 WEST 3RD ST. P.O. BOX 1740 Tempe, AZ 85281 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-06-05 |
| Decision Date | 1987-10-30 |