Name: Predicase
Price: 199 USD

K-number	K990333
Device name	MEDTRONIC PS MEDICAL INTRODUCER SHEATH 12F,14F,15F, MODELS 3805-012, 3805-014, 3805-015
Applicant	Medtronic PS Medical
Product code	GWG
Device class	Class II
Decision date	Apr 28, 1999
Decision	Substantially Equivalent
Regulation	882.1480

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 →

MEDTRONIC PS MEDICAL INTRODUCER SHEATH 12F,14F,15F, MODELS 3805-012, 3805-014, 3805-015

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