FDA 510(k) Applications Submitted by Shawn Fojtik
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K250013 |
01/02/2025 |
VentiV 7Fr -12Fr MP Mechanical Thrombectomy System (VS7-MP60S, VS7-MP90S, VS8-MP60S, VS8-MP90S, VS8-MP100B, VS10-MP100B, VS11-MP60S, VS11-MP90S, VS12-MP100B, 7F-MP60S, 7F-MP90S, 8F-MP60S, 8F-MP100B, 10F-MP100B, 11F-MP60S, 11F-MP90S, 11P-MP60S, 11P-MP90S, |
Control Medical Technology, Inc. / dba VentiV Scientific |
| K200629 |
03/10/2020 |
Aspire Mechanical Aspirator G |
Control Medical Technology |
| K200871 |
04/01/2020 |
Aspire MAX 7 - 11F Mechanical Thrombectomy System and Aspire Mechanical Aspirator |
Control Medical Technology |
| K011361 |
05/03/2001 |
DESAI VECTORCATH MAPPING CATHETER, DESAI VECTORCATH CONNECTOR CABLE |
CATHEFFECTS, LLC. |
| K131998 |
06/28/2013 |
ASPIRE RX-LP6 ASPIRATION CATHETER |
CONTROL MEDICAL TECHNOLOGY, LLC |
| K012089 |
07/05/2001 |
CATHEFFECTS' DESAI VECTORCATH MAPPING SYSTEM |
CATHEFFECTS, LLC. |
| K072299 |
08/17/2007 |
POWRSYRINGE ASPIRATOR |
PINYONS MEDICAL TECHNOLOGY, INC. |
| K072318 |
08/20/2007 |
POWRSYRINGE INJECTOR |
PINYONS MEDICAL TECHNOLOGY, INC. |
| K072345 |
08/21/2007 |
POWRSYRINGE MONITOR |
PINYONS MEDICAL TECHNOLOGY, INC. |
| K113757 |
12/21/2011 |
ASPIRE MAX ASPIRATION CATHETER |
CONTROL MEDICAL TECHNOLOGY, LLC |
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