The following data is part of a premarket notification filed by Medical Components Inc with the FDA for 2f & 3f Vascu-sheath Tearaway Introducer.
| Device ID | K130687 |
| 510k Number | K130687 |
| Device Name: | 2F & 3F VASCU-SHEATH TEARAWAY INTRODUCER |
| Classification | Introducer, Catheter |
| Applicant | MEDICAL COMPONENTS INC 1499 DELP DRIVE Harleysville, PA 19438 |
| Contact | Jessica Leo |
| Correspondent | Jessica Leo MEDICAL COMPONENTS INC 1499 DELP DRIVE 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 | 2013-03-13 |
| Decision Date | 2013-08-15 |
| Summary: | summary |