Company ยท US
Great Batch Medical
FDA 510(k) clearances and medical device recalls filed under this name, 2009 to 2018. Name variants (Inc, Corp, punctuation) are merged.
10510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 26, 2018 | K181855 | RadialSeal Introducer Kit Great Batch Medical | DYB |
| May 24, 2013 | K130559 | MOBICATH BI-DIRECTIONAL GUIDING SHEATH Great Batch Medical | DYB |
| Dec 19, 2012 | K122832 | MOBICATH TRANSSEPTAL NEEDLE Great Batch Medical | DRC |
| Feb 7, 2012 | K112541 | Z FLEX-270TM STEERABLE SHEATH Great Batch Medical | DRA |
| Feb 2, 2012 | K110051 | RADIALSOURCE TRANSRADIAL ACCESS INTRODUCER KIT Great Batch Medical | DYB |
| Oct 3, 2011 | K111644 | MOBICATH TRANSSEPTAL NEEDLE Great Batch Medical | DRC |
| Nov 26, 2010 | K101784 | MOBICATH BI-DIRECTIONAL GUIDING SHEATH MODEL 1000182-XXX Great Batch Medical | DYB |
| Nov 16, 2010 | K102540 | PTFE PORTABLE INTRODUCER Great Batch Medical | DYB |
| Mar 15, 2010 | K093232 | OPTISEAL ENPATH VALVED PTFE PEELABLE INTRODUCER Great Batch Medical | DYB |
| Oct 29, 2009 | K093023 | PTFE PEELABLE INTRODUCER Great Batch Medical | DYB |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||