Atlas FDA

INDEFLATOR 20/30 INFLATION DEVICE AND 20/30 PRIORITY PACK (WITH THE .096 OR .115 ROTATING HEMOSTATIC VALVE)

FDA 510(k) clearance K961471 · decided 1996-05-08

Clearance details

K-number
K961471
Device name
INDEFLATOR 20/30 INFLATION DEVICE AND 20/30 PRIORITY PACK (WITH THE .096 OR .115 ROTATING HEMOSTATIC VALVE)
Applicant
Advanced Cardiovascular Systems, Inc.
Decision
Unknown
Date received
1996-04-17
Decision date
1996-05-08
Days to decision
21 days
Clearance type
Traditional
Product code
MAV
Device class
2
Regulation number
870.1650
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Santa Clara, CA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
20/30 INDEFLATOR, REF: 1000184, for use during cardiovascular procedures in conjunction wi recall (Z-0730-2025)Abbott Vascular Inc2024-12-20
20/30 Priority Pack Accessory Kit/.096 RHV, REF: 1000186, or use during vascular procedure recall (Z-0731-2025)Abbott Vascular Inc2024-12-20
20/30 Priority Pack Accessory Kit w/Copilot, REF: 1003327, used for cardiovascular procedu recall (Z-0732-2025)Abbott Vascular Inc2024-12-20
20/30 Priority Pack Kit/.115 RHV, REF: 1000186-115, used for cardiovascular procedures. recall (Z-0733-2025)Abbott Vascular Inc2024-12-20

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