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 |