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.


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact