FDA.reportPublic FDA data

510(k) K010993

Device
ALIEN RX MICRO CANNULA, MODEL 4530
Applicant
Boston Scientific Corp
510(k) number
K010993
Product code
ODD
Decision
Substantially Equivalent (SESE)
Decision date
2001-04-30
Date received
2001-04-03
Regulation
876.1500
Classification name
Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
LIAS M QUAGLIA
Address
One Boston Scientific Pl. Natick, MA US 01760 01760

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code ODD#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
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K070420BIOSHIELD-ERCP BIOPSY VALVE, MODEL 00711138United States Endoscopy Group, Inc.2007-03-19
K011149DISPOSABLE BENDING CANNULA PR-233QThe Olympus Optical Co.2001-05-15
K973205WILSON-COOK STRICTURE MEASURING CATHETERWilson-Cook Medical, Inc.1997-11-24
K963051ERCP CANNULAUnited States Endoscopy Group, Inc.1997-03-28
K953967ENDOSCOPIC CATHETERAct Medical, Inc.1996-01-22
K950700BARD BILISYSTEM ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) CANNULAC.R. Bard, Inc.1995-04-27
K950729OLYMPUS PR-23Q DISPOSABLE CANNULA (BALL TIP)Olympus America, Inc.1995-03-17
K910769SURGITEK(R) ERCP CONTRAST MEDIA SYSTEMSurgitek Medical Engineering Corp.1991-06-25
K884709ENDOSCOPES & ACCESS.(SCLEROTHERAPY/TRANSBRONCHIAL)Primrose Medical, Inc.1989-09-08
K845018DAVOL ERCP CANNULAC.R. Bard, Inc.1985-01-15
K834414ERCP CANNULAHobbs Medical, Inc.1984-02-04
K833417ENDOSCOPIC RETROGRADEMicrovasive1983-11-28