FDA 510(k) Applications Submitted by Mary P. LeGraw
FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
K072520 |
09/07/2007 |
TEPHAFLEX SURGICAL FILM |
TEPHA, INC. |
K960501 |
02/02/1996 |
ULTRA-THIN DIAMOND BALLOON DILATATION CATHETER |
BOSTON SCIENTIFIC CORP. |
K970379 |
02/03/1997 |
CHANNEL BALLOON CATHETER |
BOSTON SCIENTIFIC CORP. |
K130326 |
02/08/2013 |
TEPHAFLEX MELTBLOWN CONSTRUCT |
TEPHA, INC. |
K010633 |
03/02/2001 |
RIGIDFIX SOFT TISSUE ACL CROSSPIN SYSTEM |
MITEK PRODUCTS |
K140533 |
03/04/2014 |
GALAFLEX MESH |
TEPHA, INC. |
K000936 |
03/23/2000 |
VAPR 2.3MM WEDGE ELECTRODE FOR USE WITH VAPR SYSTEM |
MITEK PRODUCTS |
K070894 |
03/30/2007 |
TEPHAFLEX SURGICAL MESH |
TEPHA, INC. |
K971254 |
04/03/1997 |
TRANSEND EX PLATINUM GUIDEWIRE |
BOSTON SCIENTIFIC CORP. |
K081099 |
04/17/2008 |
TEPHAFLEX ABSORBABLE SUTURE |
TEPHA, INC. |
K101287 |
05/07/2010 |
TEPHAFLEX COMPOSITE MESH |
TEPHA, INC. |
DEN060003 |
05/12/2006 |
TEPHAFLEX ABSORBABLE SUTURE |
TEPHA, INC. |
K091633 |
06/04/2009 |
TEPHAFLEX SURGICAL FILM |
TEPHA, INC. |
K972357 |
06/25/1997 |
BLUE MAX - 20 BALLOON DILATATION CATHETER |
BOSTON SCIENTIFIC CORP. |
K111946 |
07/08/2011 |
TEPHAFLEX MESH |
TEPHA, INC. |
K972744 |
07/23/1997 |
COURIER ST BALLOON DILATATION CATHETER |
BOSTON SCIENTIFIC CORP. |
K132348 |
07/29/2013 |
TEPHAFLEX BRAIDED SUTURE |
TEPHA, INC. |
K082178 |
08/01/2008 |
TEPHAFLEX ABSORBABLE SUTURE |
TEPHA, INC. |
K002422 |
08/08/2000 |
VARPR 3.5MM 90 SUCTION ELECTRODE FOR USE WITH VAPR SYSTEM |
MITEK PRODUCTS |
K973008 |
08/13/1997 |
COURIER ST BALLOON DILATATION CATHETER |
BOSTON SCIENTIFIC CORP. |
K002639 |
08/24/2000 |
BIOKNOTLESS ANCHOR |
MITEK PRODUCTS |
K963397 |
08/29/1996 |
ULTRA-THIN DIAMOND BALLOON DILATATION CATHETER |
BOSTON SCIENTIFIC CORP. |
K963691 |
09/16/1996 |
COURIER BALLOON DILATATION CATHETER |
BOSTON SCIENTIFIC CORP. |
K963988 |
10/04/1996 |
INTRAVASCULAR INFUSION DEVICE |
BOSTON SCIENTIFIC CORP. |
K964611 |
11/18/1996 |
TRANSEND GUIDEWIRE |
BOSTON SCIENTIFIC CORP. |
K113721 |
12/19/2011 |
TEPHAFLEX LIGHT MESH |
TEPHA, INC. |
K113723 |
12/19/2011 |
TEPHAFLEX MESH |
TEPHA, INC. |
K181088 |
04/25/2018 |
TSP Crosser Transseptal Access System |
Transseptal Solutions Ltd. |
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