Atlas FDA

INTRO-FLEX SHEATH INTRODUCER W/AMC THROMBOSHIELD

FDA 510(k) clearance K885179 · decided 1989-08-09

Clearance details

K-number
K885179
Device name
INTRO-FLEX SHEATH INTRODUCER W/AMC THROMBOSHIELD
Applicant
Baxter Healthcare Corp
Decision
Substantially Equivalent
Date received
1988-12-14
Decision date
1989-08-09
Days to decision
238 days
Clearance type
Traditional
Product code
DYB
Device class
2
Regulation number
870.1340
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Santa Ana, CA, 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
NAMIC Dilator and Sheath (K253526)Medline Industries, LP2026-07-29
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FieldFlex Steerable Sheath (K261492)CenterPoint Systems, LLC2026-06-05
Echo Large Bore Introducer Sheath (K260606)Echo Medical, LLC2026-04-29
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Recalls involving this device

RecordFirmDate
CENTURION Infusion Catheter, 7F, 17cm (DO), Reorder MIC17F7; Infusion Catheter with Antimi recall (Z-1048-2025)MEDLINE INDUSTRIES, LP - Northfield2025-01-29

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