The following data is part of a premarket notification filed by Martech Medical Products with the FDA for Coaxial Introducer Set.
| Device ID | K101399 |
| 510k Number | K101399 |
| Device Name: | COAXIAL INTRODUCER SET |
| Classification | Introducer, Catheter |
| Applicant | MARTECH MEDICAL PRODUCTS 1500 DELP DR. Harleysville, PA 19438 -2900 |
| Contact | Susan Pileggi |
| Correspondent | Susan Pileggi MARTECH MEDICAL PRODUCTS 1500 DELP DR. Harleysville, PA 19438 -2900 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-05-18 |
| Decision Date | 2010-06-17 |
| Summary: | summary |