Atlas FDA

MEDTRONIC EVEREST INFLATION DEVICE

FDA 510(k) clearance K942269 · decided 1994-10-18

Clearance details

K-number
K942269
Device name
MEDTRONIC EVEREST INFLATION DEVICE
Applicant
Medtronics Interventional Vascular
Decision
Substantially Equivalent
Date received
1994-05-10
Decision date
1994-10-18
Days to decision
161 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
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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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BASIXTOUCH (K130566)Merit Medical Systems, Inc.2013-06-19
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Recalls involving this device

RecordFirmDate
Medtronic Everest 20cc Inflation Device; Model Number and Catalog Number: AC2205P The Ever recall (Z-1121-2014)Medtronic Vascular2014-02-26
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
Medtronic AVE Everest PTCA Inflation Catheter 20 cc Item #AC2200 recall (Z-0625-03)Medtronic, Inc.2003-03-06

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