K-number	K880551
Device name	MODEL 439-07 AND 439-09 LIFELINE MYOCARDIAL LEAD
Applicant	Intermedics, Inc.
Product code	DTB
Device class	Class III
Decision date	Mar 7, 1988
Decision	Substantially Equivalent
Regulation	870.3680

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 →

MODEL 439-07 AND 439-09 LIFELINE MYOCARDIAL LEAD

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