FDA 510(k) Applications Submitted by Michael Mahl
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K142870 |
10/01/2014 |
Penumbra Embolectomy Aspiration System [INDIGO Aspiration System] |
PENUMBRA, INC. |
| K112545 |
09/01/2011 |
QUANTA FLASH PR3, QUANTA FLASH MPO, QUANTA FLASH GBM |
INOVA DIAGNOSTICS, INC. |
| K122923 |
09/24/2012 |
QUANTA FLASH ENA7 |
INOVA DIAGNOSTICS, INC. |
| K100769 |
03/18/2010 |
PENUMBRA SYSTEM SEPARATOR FLEX (026,032,041,054), MODELS PSF026, PSF032, PSF041, PSF054 |
PENUMBRA, INC. |
| K041027 |
04/21/2004 |
DIGITAL RADIOGRAPHY SYSTEM WITH FLAT PANEL DETECTOR, MODEL DFP8000D |
TOSHIBA MEDICAL SYSTEMS CORPORATION |
| K091368 |
05/08/2009 |
R2 DIGITALNOW HD(DIGITALNOW HD) |
HOLOGIC, INC. |
| K111380 |
05/16/2011 |
NEURON MAX SYSTEM |
PENUMBRA, INC. |
| K151623 |
06/16/2015 |
Penumbra System 110 Aspiration Tubing |
Penumbra, Inc. |
| K992155 |
06/25/1999 |
VOLUSION SMALL PARTS TRANSDUCER, MODEL S-VNW 5-10, VOLUSION ABDOMINAL TRANSDUCER, MODEL S-VAW 4-7 |
MEDISON AMERICA, INC. |
| K051763 |
06/30/2005 |
QD KNEE/FOOT COIL, MODEL MJQJ-147A |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
| K121917 |
07/02/2012 |
PENUMBRA EMBOLECTOMY ASPIRATION SYSTEM |
PENUMBRA, INC. |
| K022400 |
07/23/2002 |
SSA-700A, APLIO DIAGNOSTIC ULTRASOUND SYSTEM |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
| K032490 |
08/12/2003 |
TOSHIBA EXCELART VANTAGE XGV/AGV MRI DIAGNOSTIC SYSTEM, MODELS MRT-1503/P3 AND MRT-1503/P2 |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
| K142321 |
08/19/2014 |
Benchmark Intracranial Access System |
PENUMBRA, INC. |
| K142458 |
09/02/2014 |
Penumbra System ACE |
PENUMBRA, INC. |
| K152541 |
09/04/2015 |
Penumbra System ACE 64 and ACE 68 Reperfusion Catheters |
PENUMBRA, INC. |
| K202821 |
09/24/2020 |
Indigo Aspiration System - Aspiration Catheter 12 and Separator 12 |
Penumbra, Inc. |
| K023207 |
09/25/2002 |
OPART (INCLUDING OPART ULTRA AND ULTRA GRADIENT UPGRADE KIT) |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
| K052884 |
10/13/2005 |
MODEL DFP-8000D/FPD DIGITAL RADIOGRAPHY SYSTEM WITH FLAT PANEL DETECTOR |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
| K162901 |
10/17/2016 |
Penumbra 3D Revascularization Device |
Penumbra, Inc. |
| K023511 |
10/21/2002 |
EXCELART WITH PIANISSIMO XG/AG SPIN EDITION, MODEL MRT-1501/P3, P2 |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
| K173761 |
12/11/2017 |
Penumbra System Reperfusion Catheter JET 7 |
Penumbra, Inc. |
| K063761 |
12/20/2006 |
ACUSON P10 DIAGNOSTIC ULTRASOUND SYSTEM |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K063803 |
12/22/2006 |
ACUSON ANTARES DIAGNOSTIC ULTRASOUND SYSTEM |
SIEMENS MEDICAL SOLUTIONS USA, INC., ULTRASOUND DI |
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