The following data is part of a premarket notification filed by Impra, Inc. with the FDA for Impra Dual Lumen Subclavian - Femoral Catheter.
| Device ID | K883592 |
| 510k Number | K883592 |
| Device Name: | IMPRA DUAL LUMEN SUBCLAVIAN - FEMORAL CATHETER |
| Classification | Catheter, Subclavian |
| 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 | LFJ |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent - With Drug (SESD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-08-23 |
| Decision Date | 1988-12-08 |