Atlas FDA

CATHETER SECUREMENT DEVICE

FDA 510(k) clearance K951092 · decided 1995-03-24

Clearance details

K-number
K951092
Device name
CATHETER SECUREMENT DEVICE
Applicant
Baxter Healthcare Corp
Decision
Substantially Equivalent
Date received
1995-03-09
Decision date
1995-03-24
Days to decision
15 days
Clearance type
Traditional
Product code
BSO
Device class
2
Regulation number
868.5120
Medical specialty
Anesthesiology
Advisory committee
Anesthesiology
Location
Deerfield Lake, IL, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Baxter Healthcare Corp

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
EDEN ControlCath (K241410)Jmt Co., Ltd.2025-02-13
Perifix FX Catheter; Contiplex FX Catheter (K231242)B.Braun Medical, Inc.2023-09-15
Arrow Non-Stimulating SnapLock Adapter (K-05520-005C); Arrow Non-Stimulating Next Gen SnapLock Adapter (Luer Connection) (CA-000010-19); Arrow Non-Stimulating Next Gen SnapLock Adapter (Neuraxial Connection) (CA-000014-19); Arrow Stimulating SnapLock Adapter (with cable) (TZ-02060-001); Arrow Stimulating SnapLock Adapter (with tab) (TZ-05000-002) (K230603)Teleflex Medical2023-08-30
SubQKath Catheter and Needle Set (K193664)Hk Surgical2020-09-09
Percutaneous Introducer (K200624)Epimed International, Inc.2020-04-27
C-CAT Anaesthesia Catheter kit (K191470)Cimpax Aps2019-10-25
Medline Reinforced Epidural Catheter (K181782)Medline Industries, Inc.2019-03-04
EPINAUT (K173541)Imedicom Co., Ltd.2018-08-24
Catheter Clamping Adapter LUER 80369-7, Catheter Clamping Adapter NRFit 80369-7 (K172777)PAJUNK GmbH Medizintechnologie2018-05-03
B. Braun Tear-Away Introducer Needle (K171584)B.Braun Medical, Inc.2017-12-22
Certa Catheter (K171193)Ferrosan Medical Devices Sp. Z.O.O.2017-12-18
UltraCath Continuous Nerve block Catheter (K162522)Teleflexmedical, Inc.2017-03-17

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