K-number	K964021
Device name	INTRAMED SIDE BRANCH OCCLUSION (SBO) SYSTEM (700095 AND 700099)
Applicant	Baxter Edwards
Product code	HCG
Device class	Class II
Decision date	Mar 27, 1997
Decision	Substantially Equivalent
Regulation	882.5950

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 →

INTRAMED SIDE BRANCH OCCLUSION (SBO) SYSTEM (700095 AND 700099)

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