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FDA 510(k)

SURFLO Hybria Closed System Safety IV Catheter

K-Number: K252398 · 2025-12-17

ApplicantTerumo Medical Products (Hangzhou) Co., Ltd.
Decision Date2025-12-17
Product CodeFOZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SURFLO Hybria Closed System Safety IV Catheter is a medical device manufactured by Terumo Medical Products (Hangzhou) Co., Ltd.. It received FDA 510(k) clearance on 2025-12-17 under approval number K252398. The device is classified under product code FOZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURFLO Hybria Closed System Safety IV Catheter?

SURFLO Hybria Closed System Safety IV Catheter is a medical device that received FDA 510(k) clearance on 2025-12-17. It is manufactured by Terumo Medical Products (Hangzhou) Co., Ltd.. The 510(k) number is K252398.

When was SURFLO Hybria Closed System Safety IV Catheter approved by the FDA?

SURFLO Hybria Closed System Safety IV Catheter received FDA 510(k) clearance on 2025-12-17, under approval number K252398.

What company makes SURFLO Hybria Closed System Safety IV Catheter?

SURFLO Hybria Closed System Safety IV Catheter is manufactured by Terumo Medical Products (Hangzhou) Co., Ltd..

What is the FDA product code for SURFLO Hybria Closed System Safety IV Catheter?

The FDA product code for SURFLO Hybria Closed System Safety IV Catheter is FOZ.

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Related PubMed Literature

PMID: 42168293 Comparative in vitro and in vivo assessment of three experimental extracellular matrix meshes for soft tissue remodeling. Scientific reports (2026) PMID: 42056377 Signal detection of adverse events in medical devices using natural language processing: a case study in pelvic mesh. Scientific reports (2026) PMID: 41734979 Strategies to Increase Patients' Adherence to Digital Therapeutics for Musculoskeletal Diseases: A Narrative Review. Yonsei medical journal (2026) PMID: 41619565 Integration of materiovigilance in Unani medicine: A step towards patient safety. Journal of Ayurveda and integrative medicine (2026)

Other Devices by Terumo Medical Products (Hangzhou) Co., Ltd.

K220934RADIFOCUS Torque Device K221411Surflo Winged Infusion Set K252402Midline Catheter

Related Devices (Code: FOZ)

K162894AccuCath Intravascular CatheterC.R. Bard, Inc. K161779MedSource TrueSafe Safety IV Catheter, MedSource TrueSafe Comfort Safety IV CatheterMedsource International, LLC K162377PowerGlide Pro Midline CatheterC.R. Bard, Inc. K161866BioFlo Midline CatheterNavilyst Medical, Inc. K161777BD Nexiva and BD Nexiva Diffusics Closed IV Catheter SystemsBecton Dickinson Infusion Therapy Systems, Inc. K160592SUPERCATH 6Togo Medikit Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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