Name: Predicase
Price: 199 USD

K-number	K241042
Device name	SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198)
Applicant	Pressure Products Medical Device Manufacturing, LLC
Product code	DRC
Device class	Class II
Decision date	May 17, 2024
Decision	Substantially Equivalent
Regulation	870.1390

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 →

SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198)

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