Atlas FDA

CAPD ULTRAVIOLET(U.V.) GERMICIDAL EXCHANGE DEV SYS

FDA 510(k) clearance K883239 · decided 1988-10-21

Clearance details

K-number
K883239
Device name
CAPD ULTRAVIOLET(U.V.) GERMICIDAL EXCHANGE DEV SYS
Applicant
Baxter Healthcare Corp
Decision
Substantially Equivalent
Date received
1988-08-01
Decision date
1988-10-21
Days to decision
81 days
Clearance type
Traditional
Product code
KDJ
Device class
2
Regulation number
876.5630
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Round Lake, IL, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Baxter CAPD Solution Transfer Set for use with UV-Flash Germicidal Exchange Device, 1.2 m recall (Z-0301-05)Baxter Healthcare Renal Div2004-12-09

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