Atlas FDA

SWAN-GANZ THERMODILUTION EJECTION FRACTION/VOLUME

FDA 510(k) clearance K896466 · decided 1990-02-08

Clearance details

K-number
K896466
Device name
SWAN-GANZ THERMODILUTION EJECTION FRACTION/VOLUME
Applicant
Baxter Healthcare Corp
Decision
Substantially Equivalent
Date received
1989-11-13
Decision date
1990-02-08
Days to decision
87 days
Clearance type
Traditional
Product code
DYG
Device class
2
Regulation number
870.1240
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Santa Ana, CA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.

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