Atlas FDA

SCIMED MODEL SM-C/VR CARDIOTOMY/VENOUS RESERVOIR

FDA 510(k) clearance K882380 · decided 1988-10-06

Clearance details

K-number
K882380
Device name
SCIMED MODEL SM-C/VR CARDIOTOMY/VENOUS RESERVOIR
Applicant
Scimed Life Systems, Inc.
Decision
Substantially Equivalent
Date received
1988-06-09
Decision date
1988-10-06
Days to decision
119 days
Clearance type
Traditional
Product code
DTN
Device class
2
Regulation number
870.4400
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Minneapolis, MN, US
Third-party review
No
Expedited review
No

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Devices cleared under the same product code - the starting set for predicate research.

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Recalls involving this device

No recalls on record reference this clearance.

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