Name: Predicase
Price: 199 USD

K-number	K011336
Device name	PRIMARY SOLUTION SET WITH UNIVERSAL SPIKE, INJECTION SITE AND MALE LUER LOCK
Applicant	Churchill Medical Systems, Inc.
Product code	FPA
Device class	Class II
Decision date	Jun 12, 2001
Decision	Substantially Equivalent
Regulation	880.5440

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 →

PRIMARY SOLUTION SET WITH UNIVERSAL SPIKE, INJECTION SITE AND MALE LUER LOCK

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