K-number	K172305
Device name	CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon Pump
Applicant	Datascope Corp.
Product code	DSP
Device class	Class II
Decision date	Oct 12, 2017
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 →

CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon Pump

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