Atlas FDA

GATOR CLIPSEAL PLUG

FDA 510(k) clearance K092563 · decided 2009-11-04

Clearance details

K-number
K092563
Device name
GATOR CLIPSEAL PLUG
Applicant
Vascular Solutions, Inc.
Decision
Substantially Equivalent
Date received
2009-08-20
Decision date
2009-11-04
Days to decision
76 days
Clearance type
Traditional
Product code
DTL
Device class
2
Regulation number
870.4290
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
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GUARDIAN II HEMOSTASIS VALVE GUARDIAN II NC HEMOSTASIS VALVE (K122301)Vascular Solutions Zerusa , Ltd.2012-09-07
MEDLINE STOPCOCK AND MANIFOLD (K120069)Medline Industries, Inc.2012-04-03
E-PASS (K113148)Synexmed(Shenzhen)Company Limited2012-02-28
TUBING, CONMNECTORS, AND ACCESSORIES WIT BALANCE BIOSURFACE (K113845)Medtronic, Inc.2012-01-25
DISPOSABLE HEMOSTATIC Y-CONNECTORS (K113132)Coeur, Inc.2012-01-20
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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