The following data is part of a premarket notification filed by Martech Medical Products with the FDA for Ptfe Super Sheath Introducer.
| Device ID | K130855 |
| 510k Number | K130855 |
| Device Name: | PTFE SUPER SHEATH INTRODUCER |
| Classification | Introducer, Catheter |
| Applicant | MARTECH MEDICAL PRODUCTS 1500 DELP DR. Harleysville, PA 19438 -2900 |
| Contact | Alexis Erazo |
| Correspondent | Alexis Erazo 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 | 2013-03-28 |
| Decision Date | 2013-07-29 |
| Summary: | summary |