FDA 510(k) Applications Submitted by Chester McCoy
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K010035 |
01/04/2001 |
IVS TUNNELLER |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
| K970113 |
01/13/1997 |
ULTRA-BLEND PLUS |
ULTRADENT PRODUCTS, INC. |
| K970114 |
01/13/1997 |
ULTRACAL XS |
ULTRADENT PRODUCTS, INC. |
| K980726 |
02/24/1998 |
ULTRA-BLASTER |
ULTRADENT PRODUCTS, INC. |
| K000659 |
02/28/2000 |
MODIFICATION TO SOFTOUCH DIAGNOSTIC INTRAVASCULAR CAT |
MERIT MEDICAL SYSTEMS, INC. |
| K040594 |
03/08/2004 |
HERCULON SOFT TISSUE REATTACHMENT SYSTEM |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
| K210719 |
03/10/2021 |
Change Healthcare Anatomical AI |
Change Healthcare Canada Company |
| K990975 |
03/23/1999 |
IN-LINE HEMOSTASIS VALVE |
MERIT MEDICAL SYSTEMS, INC. |
| K971284 |
04/07/1997 |
OPALDAM |
ULTRADENT PRODUCTS, INC. |
| K981596 |
05/04/1998 |
ULTRAPAK E |
ULTRADENT PRODUCTS, INC. |
| K991619 |
05/11/1999 |
FOUNTAIN Infusion Catheter and Occluding Guide Wire |
MERIT MEDICAL SYSTEMS, INC. |
| K971898 |
05/22/1997 |
PERMALUTE, TRY-IN PASTE |
ULTRADENT PRODUCTS, INC. |
| K971899 |
05/22/1997 |
ENDO-SEAL |
ULTRADENT PRODUCTS, INC. |
| K992231 |
07/02/1999 |
FOUNTAIN Infusion Catheter and Occluding Guide Wire |
MERIT MEDICAL SYSTEMS, INC. |
| K002289 |
07/27/2000 |
INQWIRE DIAGNOSTIC GUIDE WIRE |
MERIT MEDICAL SYSTEMS, INC. |
| K012539 |
08/07/2001 |
VERASTEP |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
| K212528 |
08/11/2021 |
Change Healthcare Cardiology |
Change Healthcare Israel Ltd. |
| K032696 |
09/02/2003 |
AUTO SUTURE ENDOSCOPIC (& OPEN) TA SURGICAL STAPLER, AUTO SUTURE ENDOSCOPIC (& OPEN) GIA SURGICAL STAPLING INSTRUMENT |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
| K993057 |
09/13/1999 |
MBA |
MERIT MEDICAL SYSTEMS, INC. |
| K003078 |
10/03/2000 |
MERIT DRAINAGE DEPOT |
MERIT MEDICAL SYSTEMS, INC. |
| K993341 |
10/05/1999 |
INTELLISYSTEM II COLOR MONITOR |
MERIT MEDICAL SYSTEMS, INC. |
| K974282 |
11/14/1997 |
VITALESCENCE |
ULTRADENT PRODUCTS, INC. |
| K974283 |
11/14/1997 |
PQ 1 |
ULTRADENT PRODUCTS, INC. |
| K013860 |
11/21/2001 |
AUTO SUTURE SURGICAL STAPLES |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
| K974413 |
11/24/1997 |
PERMAFLO |
ULTRADENT PRODUCTS, INC. |
| K964809 |
11/29/1996 |
SPETEMP EF |
ULTRADENT PRODUCTS, INC. |
| K964810 |
11/29/1996 |
DERMADAM |
ULTRADENT PRODUCTS, INC. |
| K994253 |
12/17/1999 |
VACLOK SYRINGE |
MERIT MEDICAL SYSTEMS, INC. |
| K974786 |
12/22/1997 |
PREPQUICK |
ULTRADENT PRODUCTS, INC. |
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