Atlas FDA

SCI MED TUBING CONNECTORS

FDA 510(k) clearance K831261 · decided 1983-06-03

Clearance details

K-number
K831261
Device name
SCI MED TUBING CONNECTORS
Applicant
Scimed Life Systems, Inc.
Decision
Substantially Equivalent
Date received
1983-04-18
Decision date
1983-06-03
Days to decision
46 days
Clearance type
Traditional
Product code
DTL
Device class
2
Regulation number
870.4290
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Mchenry, IL, 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.

RecordFirmDate
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GUARDIAN II HEMOSTASIS VALVE GUARDIAN II NC HEMOSTASIS VALVE (K122301)Vascular Solutions Zerusa , Ltd.2012-09-07
MEDLINE STOPCOCK AND MANIFOLD (K120069)Medline Industries, Inc.2012-04-03
E-PASS (K113148)Synexmed(Shenzhen)Company Limited2012-02-28
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DISPOSABLE HEMOSTATIC Y-CONNECTORS (K113132)Coeur, Inc.2012-01-20
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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