Name: Predicase
Price: 199 USD

K-number	K033569
Device name	FLOWMEDICA BIFURCATED INFUSION SYSTEM, INFUSION CATHETER AND INTRODUCER SHEATH
Applicant	Flowmedica, Inc.
Product code	KRA
Device class	Class II
Decision date	Jan 13, 2004
Decision	Substantially Equivalent
Regulation	870.1210

AI Summary

AI extraction for this record is queued and will appear within 24 hours. View full FDA record →

Source

View the full FDA submission: accessdata.fda.gov

Researching this as a predicate?

Want a transparent AI-ranking score, AI-discovered related predicates, ongoing safety and warning-letter monitoring, full predicate chain lineage, and a drafted SE rationale — all saved to your own project? That's what an account adds.

Start free trial →

FLOWMEDICA BIFURCATED INFUSION SYSTEM, INFUSION CATHETER AND INTRODUCER SHEATH

Everything you need for a 510(k) submission. Nothing you don't.