Invatec Llc
FDA Regulatory Profile
Invatec Llc appears in FDA public data with 1 recall, 4 510(k) clearances, 4 FDA inspections, and 1 compliance action on record. Its most recent recall (Z-1517-2013, Class II) was initiated on March 4, 2009. Its most recent 510(k) clearance was granted on April 30, 2010.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 4
- Inspections
- 4
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1517-2013 | Class II | lnvatec SpA brand Diver C.E., Model/Catalog Numbers: DVR010014145, DVR011014145, Product is man | March 4, 2009 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K100921 | ADMIRAL XTREME PTA BALLOON DILATATION CATHETER | April 30, 2010 |
| K092352 | SCUBA BILIARY STENT SYSTEM | March 16, 2010 |
| K092361 | REEF HP 0.035 OTW PTA BALLOON DILATATION CATHETER | October 29, 2009 |
| K092177 | MO.MA ULTRA PROXIMAL CEREBRAL PROTECTION DEVICE, MODEL MUS0130069X6 | October 15, 2009 |