Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Introcan Safety® Deep Access XL IV Catheter

K-Number: K253235 · 2026-05-15

Decision Date2026-05-15
Product CodeFOZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Introcan Safety® Deep Access XL IV Catheter is a medical device manufactured by B.Braun Medical, Inc.. It received FDA 510(k) clearance on 2026-05-15 under approval number K253235. 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 Introcan Safety® Deep Access XL IV Catheter?

Introcan Safety® Deep Access XL IV Catheter is a medical device that received FDA 510(k) clearance on 2026-05-15. It is manufactured by B.Braun Medical, Inc.. The 510(k) number is K253235.

When was Introcan Safety® Deep Access XL IV Catheter approved by the FDA?

Introcan Safety® Deep Access XL IV Catheter received FDA 510(k) clearance on 2026-05-15, under approval number K253235.

What company makes Introcan Safety® Deep Access XL IV Catheter?

Introcan Safety® Deep Access XL IV Catheter is manufactured by B.Braun Medical, Inc..

What is the FDA product code for Introcan Safety® Deep Access XL IV Catheter?

The FDA product code for Introcan Safety® Deep Access XL IV Catheter is FOZ.

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.