Name: Predicase
Price: 199 USD

K-number	K072583
Device name	PLEGIOX CARDIOPLEGIA HEAT EXCHANGER, WITH SAFELINE COATING, MODEL(S) CHX30, BSQ-CHX 30
Applicant	Maquet Cardiopulmonary, AG
Product code	DTR
Device class	Class II
Decision date	Apr 4, 2008
Decision	Substantially Equivalent
Regulation	870.4240

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 →

PLEGIOX CARDIOPLEGIA HEAT EXCHANGER, WITH SAFELINE COATING, MODEL(S) CHX30, BSQ-CHX 30

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