FDA 510(k) Applications Submitted by PAIGE SWEENEY
FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
K020120 |
01/14/2002 |
ENDOVIVE INITIAL PLACEMENT DIRECT PEJ KIT, ENDOVIVE STANDARD PROFILE BALLOON REPLACEMENT, MODELS 6520, 6521, 6220 |
BOSTON SCIENTIFIC CORP. |
K050232 |
02/01/2005 |
RIGIFLEX SINGLE-USE ACHALASIA BALLOON DILATOR |
BOSTON SCIENTIFIC CORP. |
K160502 |
02/23/2016 |
TEG 6s Hemostasis System |
Haemonetics Corporation |
K020765 |
03/08/2002 |
MICROVASIVE ZERO TIP AIRWAY RETRIEVAL BASKET, MODELS M00513200 AND M00513210 |
BOSTON SCIENTIFIC CORP. |
K030855 |
03/18/2003 |
MODIFICATION TO ENDOVIVE INITIAL PLACEMENT PEG KIT, DIRECT PEJ KIT, PEG SAFETY KIT |
BOSTON SCIENTIFIC CORP. |
K071357 |
05/15/2007 |
P.004 NC ANATOMIC ABUTMENTS |
INSTITUT STRAUMANN AG |
K031538 |
05/16/2003 |
ENDOVIVE INITIAL PLACEMENT PEG KIT, DIRECT PEJ KIT, AND PEG SAFETY KIT |
BOSTON SCIENTIFIC CORP. |
K041827 |
07/07/2004 |
DUALFLEX RX ERCP CANNULA, MODELS 4681, 4682 |
BOSTON SCIENTIFIC CORP. |
K071919 |
07/12/2007 |
P.004 ABUTMENTS |
STRAUMANN USA (ON BEHALF OF INSTITUT STRAUMANN AG) |
K072151 |
08/03/2007 |
P.004 RC CARES TITANIUM AND CERAMIC ABUTMENTS |
STRAUMANN USA |
K022648 |
08/09/2002 |
ENDOVIVE INITIAL PLACEMENT DIRECT PEJ KIT, MODELS 6520 & 6521 |
BOSTON SCIENTIFIC CORP. |
K023337 |
10/07/2002 |
CRE PULMONARY BALLOON DILATATION CATHETER, MODELS K00550300, M00550310, M00550320, M00550330, M00550340, M00550350 |
BOSTON SCIENTIFIC CORP. |
K014297 |
12/31/2001 |
ENDOVIVE INITIAL PLACEMENT GASTROSTOMY KIT; ENDOVIVE LOW PROFILE BUTTON REPLACEMENT GASTROSTOMY TUBE; SECURI-T INITIAL P |
BOSTON SCIENTIFIC CORP. |
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