K-number	K944460
Device name	DATASCOPE INTRA-AORTIC BALLOON WITH MODIFIED STAT GARD
Applicant	Datascope Corp.
Product code	DSP
Device class	Class II
Decision date	Dec 9, 1994
Decision	Substantially Equivalent
Regulation	870.3535

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 →

Building an AI or ML-enabled device? Predicate search, PCCP tracking, and AI-specific FDA intelligence — built exclusively for AI/ML devices. Try AIFDA Intel →

DATASCOPE INTRA-AORTIC BALLOON WITH MODIFIED STAT GARD

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