Name: Predicase
Price: 199 USD

K-number	K962266
Device name	0.014 INCH EXTRA LONG FLOPPY AND 0.014 EXTRA LONG INTERMEDIATE GUIDE WIRES WITH PHOSPHORYLCHOLINE (PC) POLYMER COATING
Applicant	Biocompatibles Cardiovascular, Inc.
Product code	DQX
Device class	Class II
Decision date	Sep 10, 1996
Decision	Substantially Equivalent
Regulation	870.1330

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 →

0.014 INCH EXTRA LONG FLOPPY AND 0.014 EXTRA LONG INTERMEDIATE GUIDE WIRES WITH PHOSPHORYLCHOLINE (PC) POLYMER COATING

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