Name: Predicase
Price: 199 USD

K-number	K953044
Device name	UNIPOLAR & BIOPLAR IMPLANTABLE ENDOCARDIAL PACING LEADS, WITH SILICONE RUBBER INSULATION & PASSIVE FIXATION
Applicant	Biotronik, Inc.
Product code	DTB
Device class	Class III
Decision date	Sep 27, 1996
Decision	Substantially Equivalent - Subject to Tracking & PMS
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 →

UNIPOLAR & BIOPLAR IMPLANTABLE ENDOCARDIAL PACING LEADS, WITH SILICONE RUBBER INSULATION & PASSIVE FIXATION

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