The following data is part of a premarket notification filed by Medcomp with the FDA for Valved Tearway Introducer.
| Device ID | K090394 |
| 510k Number | K090394 |
| Device Name: | VALVED TEARWAY INTRODUCER |
| Classification | Introducer, Catheter |
| Applicant | MEDCOMP 1499 DELP DR. Harleysville, PA 19438 |
| Contact | Jean Callow |
| Correspondent | Jean Callow MEDCOMP 1499 DELP DR. Harleysville, PA 19438 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-02-17 |
| Decision Date | 2009-09-01 |
| Summary: | summary |