| 510(k) | K120917 |
| Device Name | HEADWAY DUO MICROCATHETER |
| Applicant | MICROVENTION, INC. |
| Contact | NAOMI GONG 1311 VALENCIA AVE TUSTINCA92780 |
| Product Code | DQO |
| Date Received | Mar 27, 2012 |
| Decision Date | Aug 02, 2012 |
| Decision | SE |
| Classification Advisory Committee | CV |
| Summary | Summary |
| Type | Traditional |
| Reviewd by 3rd Party | N |
| Expedited Review | N |
| source |
| Device | Date Decision |
|---|---|
| PLATO MICROCATH 27 MICROCATHETER 510k SCIENTIA VASCULAR , LLC | Jul 30, 2012 |
| NMI MICROCATHETER 510k NAVILYST MEDICAL, INC. | Jul 17, 2012 |
| HEARTRAIL III GUIDING CATHETER 510k TERUMO CORPORATION | Jul 16, 2012 |
| MONGOOSE ANGIOGRAPHIC CATHETER 510k PEDIACATH INC. | Jul 11, 2012 |
| SUREFIRE HI-FLOW MICROCATHETER 510k SUREFIRE MEDICAL, INC. | Jun 14, 2012 |
| IMPULSE AND EXPO ANGIOGRAPHIC CATHETER 510k BOSTON SCIENTIFIC CORP. | May 21, 2012 |
| ANGIODYNAMICS SOFT-VU ANGIOGRAPHIC CATHETERS 510k ANGIODYNAMICS, INC. | Mar 30, 2012 |
| IMAGER II ANGIOGRAPHIC CATHETERS 510k BOSTON SCIENTIFIC CORP. | Mar 29, 2012 |
| MODIFIED CONCENTIRC MICROCATHETER 510k CONCENTRIC MEDICAL, INC. | Mar 09, 2012 |
| SUREFIRE GUIDE SHEATH 510k SUREFIRE MEDICAL, INC | Feb 23, 2012 |
| NMI 2.8 MICROCATHETER 510k NAVILYST MEDICAL, INC. | Jan 05, 2012 |
| BIOTEQ ANGIOGRAPHIC CATHETER 510k BIOTEQUE CORP. | Sep 09, 2011 |
| MICROCATHETER 510k NAVILYST MEDICAL, INC. | Aug 19, 2011 |
| MODIFIED CONCENTRIC MICROCATHETER 510k CONCENTRIC MEDICAL, INC. | Jul 06, 2011 |
| MERIT MARQUIS FLOW SWITCH 510k MERIT MEDICAL SYSTEMS, INC. | Jul 01, 2011 |
| SUREFIRE INFUSION CATHETER SYSTEM 510k SUREFIRE MEDICAL, INC | Jun 24, 2011 |
| EDWARDS LIFESCIENCES LEFT ATRIAL PRESSURE MONITOR CATHETER 510k EDWARDS LIFESCIENCES LLC | Feb 11, 2011 |
| COHEN CROSSOVER CATHETER 510k VASCULAR SOLUTIONS, INC. | Jul 19, 2010 |
| THERMODILUTION CATHETER 510k BIOSENSORS INTL. PTE. LTD. | Jul 01, 2010 |
| VIEWFLEX PLUS ICE CATHETER 510k ST. JUDE MEDICAL | Jun 02, 2010 |