Great Batch Medical
Great Batch Medical appears in FDA public data with 0 recalls, 10 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on July 26, 2018.
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 10
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K181855 | RadialSeal Introducer Kit | July 26, 2018 |
| K130559 | MOBICATH BI-DIRECTIONAL GUIDING SHEATH | May 24, 2013 |
| K122832 | MOBICATH TRANSSEPTAL NEEDLE | December 19, 2012 |
| K112541 | Z FLEX-270TM STEERABLE SHEATH | February 7, 2012 |
| K110051 | RADIALSOURCE TRANSRADIAL ACCESS INTRODUCER KIT | February 2, 2012 |
| K111644 | MOBICATH TRANSSEPTAL NEEDLE | October 3, 2011 |
| K101784 | MOBICATH BI-DIRECTIONAL GUIDING SHEATH MODEL 1000182-XXX | November 26, 2010 |
| K102540 | PTFE PORTABLE INTRODUCER | November 16, 2010 |
| K093232 | OPTISEAL ENPATH VALVED PTFE PEELABLE INTRODUCER | March 15, 2010 |
| K093023 | PTFE PEELABLE INTRODUCER | October 29, 2009 |