Atlas FDA

STOPCOCK MANIFOLD GANGS

FDA 510(k) clearance K962581 · decided 1996-08-28

Clearance details

K-number
K962581
Device name
STOPCOCK MANIFOLD GANGS
Applicant
Baxter Healthcare Corp
Decision
Substantially Equivalent
Date received
1996-07-01
Decision date
1996-08-28
Days to decision
58 days
Clearance type
Traditional
Product code
FMG
Device class
2
Regulation number
880.5440
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
Round Lake, IL, 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
Qitexio® 4-Way Stopcock (QIT014) (K242255)Medex2025-04-29
Three Way Stop Cock (K223499)M/S Romsons International2023-07-21
lntravascular Administration Sets with Stopcock and Manifold (K223175)Baxter Healthcare Corporation2023-03-10
SafePort(TM) Manifold (or Stopcock) (K211204)Elcam Medical Acal2022-09-15
Clicky Cross (K210516)Yomura Technologies, Inc.2022-05-16
TurnSignal Stopcocks Sterile, TurnSignal Stopcocks Buld Non Sterile, TurnSignal Stopcocks with Manifolds Sterile, TurnSignal Stopcocks with Manifolds Bulk Non Sterile (K190539)Monumedical, LLC2019-10-22
Elcam Stopcocks and Manifolds (K190489)Elcam Medical Acal2019-04-23
Dynarex Three-Way Stopcock (K172266)Dynarex Corporation2018-03-14
ELCAM STOPCOCKS AND MANIFOLDS (K141254)Elcam Medical Acal2014-07-30
DISPOSABLE HIGH PRESSURE STOPCOCK/MANIFOLD MODEL HP STOPCOCK, MP STOPCOCK, HP MANIFOLD, PHP MANIFOLD (K123084)Elcam Medical Acal2013-05-23
LARGE BORE STOPCOCK WITH ROTATING MALE LUER LOCK/LARGE BORE STOPCOCK WITH EXTENSION SET, GANG LARGE BORE STOPCOCK MANIFO (K130245)Baxter Healthcare Corp2013-03-01
DUAL SYRINGE HOLDER (K082110)Surgin Surgical Instrumentation, Inc.2009-06-17

Recalls involving this device

RecordFirmDate
Baxter Interlink System Continu-Flo Solution Set, 71" (1.8 m), 2 Injection Sites, Male Lue recall (Z-0469-2012)Baxter Healthcare Corp.2012-01-11
Baxter Interlink System Continu-Flo Solution Set, 69" (1.8 m), 2 Injection Sites, Male Lue recall (Z-0470-2012)Baxter Healthcare Corp.2012-01-11
Baxter Interlink System Solution Set, 67" (1.7 m), Injection Site, Male Luer Lock Adapter, recall (Z-0479-2012)Baxter Healthcare Corp.2012-01-11
Baxter Interlink System Continu-Flo Solution Set, 71" (1.8 m), 2 Injection Sites, Male Lue recall (Z-0480-2012)Baxter Healthcare Corp.2012-01-11
Baxter Interlink System Large Bore 4-Way Stopcock, Volume 0.65 mL, Injection Site, Rotatin recall (Z-2623-2011)Baxter Healthcare Corp.2011-06-22
Baxter Three-Way Large Bore Stopcock with Rotating Male Luer Lock Adapter; a sterile, nonp recall (Z-0586-2011)Baxter Healthcare Corp.2010-12-09
Baxter Three-Way Large Bore Stopcock with Male Luer Slip; a sterile, nonpyrogenic fluid pa recall (Z-0587-2011)Baxter Healthcare Corp.2010-12-09
Baxter Interlink System Non-DHEP Extension Set; 8.3" (21.0 cm), Volume 1.4 mL, Large Bore recall (Z-0151-2011)Baxter Healthcare Corp.2010-10-27
Baxter Interlink System Extension Set with Standard Bore 4-Way Stopcock Manifold Extension recall (Z-0646-06)Baxter Healthcare Corp.2006-03-24
Baxter Interlink System Continu-Flo Solution Set with Standard Bore 4-Way Stopcock Manifol recall (Z-0653-06)Baxter Healthcare Corp.2006-03-24
Baxter Interlink System Buretrol Solution Set with Large Bore 3-Way Stopcock with Rotating recall (Z-0654-06)Baxter Healthcare Corp.2006-03-24
Baxter Interlink System Buretrol Solution Set with Large Bore 4-Way Stopcock Extension Set recall (Z-0655-06)Baxter Healthcare Corp.2006-03-24
Baxter Interlink System Buretrol Solution Set with Large Bore 4-Way Stopcock with Rotating recall (Z-0656-06)Baxter Healthcare Corp.2006-03-24
Baxter ClearLink Intravenous (IV) Solution Sets and Extension Sets that have a ClearLink l recall (Z-0845-05)Baxter Healthcare Corp.2005-05-17

PMA approvals by this applicant

RecordFirmDate
Floseal Hemostatic Matrix, Floseal with Recothrom; Floseal Hemostatic Matrix, Floseal Fast Prep; 3 Floseal Hemostatic Ma (P990009/S077)Baxter Healthcare Corp2025-11-13
FLOSEAL MATRIX/FLOSEAL MATRIX HEMOSTATIC SEALANT/PROCEED HEMOSTATIC SEALANT (P990009/S076)Baxter Healthcare Corp2025-06-30
Floseal Hemostatic Matrix (P990009/S075)Baxter Healthcare Corp2025-01-30
Adept Adhesion Reduction Solution (P050011/S009)Baxter Healthcare Corp2024-08-23
Floseal Hemostatic Matrix, Floseal with Recothrom, Floseal Hemostatic Matrix, Floseal Fast Prep (P990009/S074)Baxter Healthcare Corp2024-08-15
Floseal Hemostatic Matrix (P990009/S073)Baxter Healthcare Corp2024-01-10
Floseal Hemostatic Matrix, Fast Prep, Floseal Hemostatic Matrix, RTS (P990009/S072)Baxter Healthcare Corp2023-12-12
Floseal Hemostatic Matrix, RT5 (P990009/S070)Baxter Healthcare Corp2023-02-02