Atlas FDA

SCIMED 8 FRENCH WISEGUIDE GUIDE CATHETER

FDA 510(k) clearance K970823 · decided 1997-06-03

Clearance details

K-number
K970823
Device name
SCIMED 8 FRENCH WISEGUIDE GUIDE CATHETER
Applicant
Scimed Life Systems, Inc.
Decision
Substantially Equivalent
Date received
1997-03-06
Decision date
1997-06-03
Days to decision
89 days
Clearance type
Traditional
Product code
DQY
Device class
2
Regulation number
870.1250
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Maple Grove, MN, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Boston Scientific Wiseguide, Guide Catheter, Sterilized with ethylene oxide gas, Made in M recall (Z-2013-2009)Boston Scientific Corporation2009-09-04
Boston Scientific Wiseguide Guide Catheter, Sterilized. Wiseguide catheters are intended f recall (Z-1470-2009)Boston Scientific Corporation2009-06-18

PMA approvals by this applicant

RecordFirmDate
APEX MONORAIL & APEX OTW PTCA DILATATION CATHETER/MAVERICK2 MONORAIL PTCA CATHETER/MAVERICK OTW PTCA CATHETER/MAVERICK (P860019/S264)Scimed Life Systems, Inc.2011-03-31
APEX PTCA & NC QUANTUM APEX PTCA CATHETERS (P860019/S263)Scimed Life Systems, Inc.2010-09-08
MAVERICK2 MONORAIL PTCA DILATATION CATHETER (P860019/S261)Scimed Life Systems, Inc.2010-09-08
PTCA CATHETERS (MAVERICK2/MAVERICK/MAVERICK XL/QUANTUM/MAVERICK/APEX) (P860019/S260)Scimed Life Systems, Inc.2010-09-01
PTCA CATHETERS (P860019/S259)Scimed Life Systems, Inc.2010-08-13
BSC APEX MONORAIL & OTW PTCA DILATATION CATHETERS (P860019/S258)Scimed Life Systems, Inc.2010-07-28
MAVERICK2 MONORAIL & MAVERICK OTW PTCA DILATATION CATHETERS (P860019/S256)Scimed Life Systems, Inc.2010-06-23
APEX PTCA DILATATION CATHETER (P860019/S255)Scimed Life Systems, Inc.2010-05-27