510(k) K101784 ยท DYB Introducer, Catheter
MOBICATH BI-DIRECTIONAL GUIDING SHEATH MODEL 1000182-XXX
| Applicant | Great Batch Medical, Plymouth MN, US |
| Decision | Substantially Equivalent, Nov 26, 2010 |
| Received | Jun 25, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K101784
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 19, 2016 | New Star Lasers, Inc. CT3Plus (a.k.a. CT3PZ);
Catalog number: 7300-0038/ 7300-0038-1.
Dermatology: For use in dermatology for incision, excision, ablation, and vaporization with hemostasis of soft tissue;
For treatment o Terminated |
GEX | None listed |
| Dec 22, 2012 | Greatbatch Medical Biosense Webster MobiCath Bi-Directional Guiding Sheath. Small Curve catalog no. D140010, Large Curve catalog no. D140011. The MobiCath Bi-Directional Guiding Sheath is a flexible tipped percutaneou Terminated |
DYB | None listed |
| Oct 24, 2012 | Greatbatch Medical Biosense Webster MobiCath Bi-Directional Guiding Sheath. Small Curve catalog no. D140010, Large Curve catalog no. D140011. The MobiCath Bi-Directional Guiding Sheath is a flexible tipped percutaneou Terminated |
DYB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.