Name: Predicase
Price: 199 USD

K-number	K100842
Device name	PTA-PLUS PTA BALLOON CATHER 5 MM X 4CM, PTA-PLUS PTA BALLOON CATHETER 6MM X 4CM
Applicant	Hotspur Technologies
Product code	DXE
Device class	Class II
Decision date	Jul 12, 2010
Decision	Substantially Equivalent
Regulation	870.5150

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 →

PTA-PLUS PTA BALLOON CATHER 5 MM X 4CM, PTA-PLUS PTA BALLOON CATHETER 6MM X 4CM

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