The following data is part of a premarket notification filed by Medcomp (medical Components, Inc.) with the FDA for Ptfe Super Sheath Introducer 2.1.
| Device ID | K153246 |
| 510k Number | K153246 |
| Device Name: | PTFE Super Sheath Introducer 2.1 |
| Classification | Introducer, Catheter |
| Applicant | MEDCOMP (MEDICAL COMPONENTS, INC.) 1499 DELP DR. Harleysville, PA 19438 |
| Contact | Courtney Nix |
| Correspondent | Courtney Nix 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 | 2015-11-09 |
| Decision Date | 2016-02-12 |
| Summary: | summary |