Atlas FDA

Fluent Inflation Device

FDA 510(k) clearance K152387 · decided 2015-12-18

Clearance details

K-number
K152387
Device name
Fluent Inflation Device
Applicant
Vascular Solutions, Inc.
Decision
Unknown
Date received
2015-08-24
Decision date
2015-12-18
Days to decision
116 days
Clearance type
Traditional
Product code
MAV
Device class
2
Regulation number
870.1650
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Minneapolis, MN, 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
basixTOUCH40 Inflation Syringe (K153672)Merit Medical Systems, Inc.2016-01-20
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.

PMA approvals by this applicant

RecordFirmDate
Duett Sealing Device (D-Stat Flowable) (P990037/S036)Vascular Solutions, Inc.2022-11-04
Duett Sealing Device (P990037/S035)Vascular Solutions, Inc.2021-07-13
D-Stat Flowable hemostat (P990037/S034)Vascular Solutions, Inc.2016-10-05
D-STAT FLOWABLE HEMOSTAT (P990037/S032)Vascular Solutions, Inc.2016-02-25
VASCULAR SOLUTIONS DUETT SEALING DEVICE (P990037/S031)Vascular Solutions, Inc.2010-09-15
VASCULAR SOLUTIONS DUETT SEALING DEVICE (P990037/S030)Vascular Solutions, Inc.2010-05-07
D-STAT FLOWABLE HEMOSTAT (P990037/S029)Vascular Solutions, Inc.2009-12-02
DUETT PRO SEALING DEVICE, MODEL 1010 (P990037/S028)Vascular Solutions, Inc.2008-12-17