Atlas FDA

FOGARTY(R) THRU-LUMEN EMBOLECTOMY CATHETER

FDA 510(k) clearance K892410 · decided 1989-07-20

Clearance details

K-number
K892410
Device name
FOGARTY(R) THRU-LUMEN EMBOLECTOMY CATHETER
Applicant
Baxter Healthcare Corp
Decision
Substantially Equivalent
Date received
1989-04-07
Decision date
1989-07-20
Days to decision
104 days
Clearance type
Traditional
Product code
DXE
Device class
2
Regulation number
870.5150
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

RecordFirmDate
Fogarty Thru-Lumen Embolectomy Catheter, REF: 12TLW805F35 recall (Z-0238-2024)Edwards Lifesciences, LLC2023-11-06

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