Name: Predicase
Price: 199 USD

K-number	K090752
Device name	PENUMBRA SYSTEM (PENNUMBRA REPERFUSION CATHETER 054), MODEL PSC054; (PENUMBRA SEPARATOR 054), MODEL PSS054
Applicant	Penumbra, Inc.
Product code	NRY
Device class	Class II
Decision date	Sep 21, 2009
Decision	Substantially Equivalent
Regulation	870.1250

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 →

PENUMBRA SYSTEM (PENNUMBRA REPERFUSION CATHETER 054), MODEL PSC054; (PENUMBRA SEPARATOR 054), MODEL PSS054

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