The following data is part of a premarket notification filed by Medcomp (medical Components, Inc.) with the FDA for Valved Tearaway Introducer Generation Ii.
| Device ID | K132498 |
| 510k Number | K132498 |
| Device Name: | VALVED TEARAWAY INTRODUCER GENERATION II |
| Classification | Introducer, Catheter |
| Applicant | MEDCOMP (MEDICAL COMPONENTS, INC.) 1499 DELP DR. Harleysville, PA 19438 |
| Contact | Timothy Holwick |
| Correspondent | Timothy Holwick MEDCOMP (MEDICAL COMPONENTS, INC.) 1499 DELP DR. Harleysville, PA 19438 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-08-09 |
| Decision Date | 2013-11-25 |