Name: Predicase
Price: 199 USD

K-number	K180412
Device name	Indigo Aspiration System (CAT RX and Separator 4)- Penumbra Engine Pump and Canister
Applicant	Penumbra, Inc.
Product code	QEW
Device class	Class II
Decision date	May 15, 2018
Decision	Substantially Equivalent
Regulation	870.5150

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 →

Indigo Aspiration System (CAT RX and Separator 4)- Penumbra Engine Pump and Canister

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