Atlas FDA

MULTI-PORT MANIFOLD

FDA 510(k) clearance K932512 · decided 1994-02-22

Clearance details

K-number
K932512
Device name
MULTI-PORT MANIFOLD
Applicant
Baxter Healthcare Corp
Decision
Substantially Equivalent
Date received
1993-05-25
Decision date
1994-02-22
Days to decision
273 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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Devices cleared under the same product code - the starting set for predicate research.

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Recalls involving this device

RecordFirmDate
Baxter Interlink System 3-Port Manifold with Check Valves, Vol. 1.0 mL, Large Bore 4-Way S recall (Z-0476-2012)Baxter Healthcare Corp.2012-01-11
Baxter Interlink System Continu-Flo Solution Set, length 89" (2.3 m), 2 Injection Sites, M recall (Z-0477-2012)Baxter Healthcare Corp.2012-01-11
Baxter Interlink System Continu-Flo Solution Set, length 89" (2.3 m), 2 Injection Sites, M recall (Z-0478-2012)Baxter Healthcare Corp.2012-01-11

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