← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

FOZ — Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days

DEVICE CLASS
Class II
REGULATION
21 CFR 880.5200
MEDICAL SPECIALTY
General Hospital
REVIEW PANEL
HO
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
18
510(K)/PMA CLEARANCES
510k: 18
0
RECALL ENTRIES

Recent clearances

K261041MedSource Labs, LLC · 510k2026-07-10
K260539MedSource Labs, LLC · 510k2026-07-09
K253235B.Braun Medical, Inc. · 510k2026-05-15
K252137Becton Dickinson Infusion Therapy Systems, Inc. · 510k2026-04-02
K252513Poly Medicure Limited · 510k2026-04-01
K252398Terumo Medical Products (Hangzhou) Co., Ltd. · 510k2025-12-17
K252677Poly Medicure Limited · 510k2025-11-05
K251422Becton Dickinson Infusion Therapy Systems, Inc. · 510k2025-10-08

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →