Atlas FDA

Everest 20 Disposable Inflation Device, Everest 20 Survival Kit, Everest 30 Disposable Inflation Device, Everest 30 Survival Kit

FDA 510(k) clearance K153038 · decided 2016-04-13

Clearance details

K-number
K153038
Device name
Everest 20 Disposable Inflation Device, Everest 20 Survival Kit, Everest 30 Disposable Inflation Device, Everest 30 Survival Kit
Applicant
Medtronic, Inc.
Decision
Unknown
Date received
2015-10-19
Decision date
2016-04-13
Days to decision
177 days
Clearance type
Special
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
basixTOUCH40 Inflation Syringe (K153672)Merit Medical Systems, Inc.2016-01-20
Fluent Inflation Device (K152387)Vascular Solutions, Inc.2015-12-18
MASTRO PLUS BALLOON IN-DEFLATION DEVICE (K140943)Beijing Demax Medical Technology Co.,Ltd2015-03-05
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
ENCORE 26 ADVANTAGE KIT (K123214)Boston Scientific Corp2012-11-13

Recalls involving this device

No recalls on record reference this clearance.

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