Atlas FDA

MEDTRONIC EVERST 30 INFLATION DEVICE/SURVIVAL KIT

FDA 510(k) clearance K960983 · decided 1996-05-30

Clearance details

K-number
K960983
Device name
MEDTRONIC EVERST 30 INFLATION DEVICE/SURVIVAL KIT
Applicant
Medtronics Interventional Vascular
Decision
Substantially Equivalent
Date received
1996-03-11
Decision date
1996-05-30
Days to decision
80 days
Clearance type
Traditional
Product code
MAV
Device class
2
Regulation number
870.1650
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Danvers, MA, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

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

RecordFirmDate
Everest 20 Inflation Device and 3-way Stopcock (AC2200);Everest 30 Inflation Device and 3-way Stopcock (AC3200);Everest 20 Survival Kit containing:1. Everest 20 Device with 3-way Stopcock, 2. Piton Y-Adaptor ,3. Metal Guidewire Insertion Needle, 4. Torque Handle (AC2205P); Everest 30 Survival Kit containing:1. Everest 30 Device with 3-way Stopcock, 2. Piton Y-Adaptor,3. Metal Guidewire Insertion Needle, 4. Torque Handle (AC3205P) (K220773)Medtronic Vascular2022-04-13
Fluent inflation device (K162272)Vascular Solutions, Inc.2016-10-20
Everest 20 Disposable Inflation Device, Everest 20 Survival Kit, Everest 30 Disposable Inflation Device, Everest 30 Survival Kit (K153038)Medtronic, Inc.2016-04-13
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Fluent Inflation Device (K152387)Vascular Solutions, Inc.2015-12-18
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Presto Inflation Device (K143522)C.R. Bard, Inc.2015-01-12
SUMMED INFLATION DEVICE KIT (K133795)Sunny Medical Device (Shenzhen) Co., Ltd.2014-12-12
ENCORE 26 ADVANTAGE KIT (K140745)Boston Scientific Corp2014-04-17
BASIXTOUCH (K130566)Merit Medical Systems, Inc.2013-06-19
BASIXCONPAK ANALOG INFLATION SYRINGE (K122321)Merit Medical Ireland, Ltd.2012-12-19
OXTI INFLATION DEVICE (K122152)Oxti Corporation2012-12-14

Recalls involving this device

RecordFirmDate
Medtronic Everest 20 Disposable Inflation Device, AC2200. Used to inflate/deflate balloon recall (Z-2271-2010)Medtronic, Inc.2010-08-25
Medtronic Everest 30 Disposable Inflation Device, AC3200. Used to inflate/deflate balloon recall (Z-2272-2010)Medtronic, Inc.2010-08-25
Medtronic Everest 30 Disposable Inflation Device, AC3205P. Used to inflate/deflate balloon recall (Z-2273-2010)Medtronic, Inc.2010-08-25

PMA approvals by this applicant

RecordFirmDate
THE MEDTRONIC ACHIEVER CORONARY BALLON DILATION CATHETER (P870036/S044)Medtronics Interventional Vascular1998-11-17
MEDTRONIC WIKTOR RIVAL CORONARY STENT SYSTEM (P960010/S001)Medtronics Interventional Vascular1998-05-21
MEDTRONIC(R)MILLENIA TM 15 CORONARY BALLOON DILATATION CATHETER (P870036/S043)Medtronics Interventional Vascular1997-08-12
MEDTRONIC(R) MS2(TM) BALLOON SHAPING TOOL (P870036/S042)Medtronics Interventional Vascular1997-07-28
MEDTRONIC WIKTOR PRIME CORONARY STENT DELIVERY SYSTEM (P960010)Medtronics Interventional Vascular1997-06-27
MEDTRONIC(R) EVERGREEN(TM) CORONARY BALLOON DILATATION CATHETERS (P870036/S041)Medtronics Interventional Vascular1997-03-07
MEDTRONIC(R) FALCON(R) CORONARY BALLOON DILATATION CATHETERS (P870036/S040)Medtronics Interventional Vascular1996-10-25
MEDTRONIC(R) MILLENIA (TM) FAMILY OF CORONARY BALLOON DILATATION CATHETERS (P870036/S038)Medtronics Interventional Vascular1996-09-25