The following data is part of a premarket notification filed by Medron, Inc. with the FDA for Continuous Arteriovenous Hemofiltration Catheter 10 Fr (cavh).
| Device ID | K971897 |
| 510k Number | K971897 |
| Device Name: | CONTINUOUS ARTERIOVENOUS HEMOFILTRATION CATHETER 10 FR (CAVH) |
| Classification | Catheter, Femoral |
| Applicant | MEDRON, INC. 3614 WEST 2100 SOUTH Salt Lake City, UT 84120 |
| Contact | Ron Wortley |
| Correspondent | Ron Wortley MEDRON, INC. 3614 WEST 2100 SOUTH Salt Lake City, UT 84120 |
| Product Code | LFK |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-22 |
| Decision Date | 1997-10-21 |
| Summary: | summary |