510(k) K130687 ยท DYB Introducer, Catheter
2F & 3F VASCU-SHEATH TEARAWAY INTRODUCER
| Applicant | Medical Components, Inc., Harleysville PA, US |
| Decision | Substantially Equivalent, Aug 15, 2013 |
| Received | Mar 13, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K130687
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 7, 2016 | Medical Components, Inc dba MedComp Tearaway Introducer, Model # VS203, VS303, 510 K # 130687, packaged individually in a pouch, 5 pouches per carton, lot # MBZ140, MBZL450, MBZV930 MBZZ490
Product Usage:
The 2F and 3F Vascu-Sheath Tea Terminated |
DYB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.