Atlas FDA

FOGARTY-HYDRAGRIP SURGICAL CLAMPS

FDA 510(k) clearance K951413 · decided 1995-08-18

Clearance details

K-number
K951413
Device name
FOGARTY-HYDRAGRIP SURGICAL CLAMPS
Applicant
Baxter Healthcare Corp
Decision
Substantially Equivalent
Date received
1995-03-28
Decision date
1995-08-18
Days to decision
143 days
Clearance type
Traditional
Product code
DXC
Device class
2
Regulation number
870.4450
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Mcgaw Park, IL, 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
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Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction Clamp (ARC) (K243627)Arc Trauma, LLC2025-12-31
Namic Radial Arm Band, 23 cm (DYNJRADBAND); Namic Radial Arm Band, 26 cm (DYNJRADBANDL) (K253070)Medline Industries, LP2025-11-20
Radial Compression Device (K232577)Ningbo Dizegens Medical Science Co.,Ltd2024-01-18
PICOCLAMP (K230281)Kono Seisakusho Co., Ltd.2023-10-23
Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S) (K221661)Compression Works, Inc.2023-03-03
VIOLA (K230248)Vascular Graft Solutions, Ltd.2023-02-28
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GEM Biover Microvascular Clamps (K221843)Synovis Micro Companies Alliance, Inc.2022-09-14

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