Name: Predicase
Price: 199 USD

K-number	K071774
Device name	JOSTRA QUADROX D DIFFUSION MEMBRANE OXYGENATOR WITH BIOLINE COATING, MODEL BE-HMOD 2000, BEQ-HMOD 2030
Applicant	Maquet Cardiopulmonary, AG
Product code	DTZ
Device class	Class II
Decision date	Jan 23, 2008
Decision	Substantially Equivalent
Regulation	870.4350

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 →

JOSTRA QUADROX D DIFFUSION MEMBRANE OXYGENATOR WITH BIOLINE COATING, MODEL BE-HMOD 2000, BEQ-HMOD 2030

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