Atlas FDA

ADVANCED CARDIOVASCULAR SYSTEMS HEMOSTATIC VALVES

FDA 510(k) clearance K854261 · decided 1985-12-04

Clearance details

K-number
K854261
Device name
ADVANCED CARDIOVASCULAR SYSTEMS HEMOSTATIC VALVES
Applicant
Advanced Cardiovascular Systems, Inc.
Decision
Substantially Equivalent
Date received
1985-10-23
Decision date
1985-12-04
Days to decision
42 days
Clearance type
Traditional
Product code
DTL
Device class
2
Regulation number
870.4290
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Mountain View, CA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
ACS Rotating Hemostatic Valve, 0.096 inch, for use with a dilatation catheter - Reference recall (Z-0390-2007)Abbott Vascular-Cardiac Therapies dba Guidant Corporation2007-02-01
ACS DUOSTAT Rotating Hemostatic Valve, 0.096 inch, for use with a dilatation catheter - Re recall (Z-0391-2007)Abbott Vascular-Cardiac Therapies dba Guidant Corporation2007-02-01

PMA approvals by this applicant

RecordFirmDate
CORONARY DILATATION CATHETERS (P810046/S240)Advanced Cardiovascular Systems, Inc.2010-10-15
VOYAGER NC CORONARY DILATATION CATHETER (P810046/S237)Advanced Cardiovascular Systems, Inc.2010-06-01
VOYAGER NC CORONARY DILATATION CATHETER (P810046/S238)Advanced Cardiovascular Systems, Inc.2010-05-13
SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETERS VOYAGER/VOYAGER NC (P810046/S236)Advanced Cardiovascular Systems, Inc.2010-04-23
VOYAGER NC CORONARY DILATATION CATHETER (P810046/S234)Advanced Cardiovascular Systems, Inc.2010-03-26
VOYAGER NC CORONARY DILATATION CATHETER (P810046/S232)Advanced Cardiovascular Systems, Inc.2010-02-04
VOYAGER NC CORONARY DILATATION CATHETER (P810046/S230)Advanced Cardiovascular Systems, Inc.2009-07-15
VOYAGER NC CORONARY DILATATION CATHETER (P810046/S231)Advanced Cardiovascular Systems, Inc.2009-05-26