Name: Predicase
Price: 199 USD

K-number	K960379
Device name	ROTABLATOR SYSTEM'S GUIDE WIRE LINE: SUPPORT ROTAWIRE RAIL ROTA WIRE
Applicant	Heart Technology Mfg., Inc.
Product code	MCW
Device class	Class II
Decision date	Apr 25, 1996
Decision	Substantially Equivalent
Regulation	870.4875

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 →

ROTABLATOR SYSTEM'S GUIDE WIRE LINE: SUPPORT ROTAWIRE RAIL ROTA WIRE

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