510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K963738Substantially Equivalent - Subject to Tracking & PMS

Stela Model Bj44 and Bj45 Pacing Leads

Ela Medical, Inc., Minnetonka MN / Traditional, Substantially Equivalent - Subject to Tracking & PMS
FDA source (opens on fda.gov)

K963738 is the FDA 510(k) clearance record for STELA MODEL BJ44 AND BJ45 PACING LEADS, a class III device, cleared for Ela Medical, Inc. on under FDA product code DTB (Permanent Pacemaker Electrode). FDA records list 43 510(k) clearances for Ela Medical, Inc., from to . As of , FDA records show no recalls naming K963738.

Clearance record

Decision date
Received
(248 days to decision)
Product code
DTB Permanent Pacemaker Electrode
Regulation
21 CFR 870.3680
Device class
Class III
Review panel
Cardiovascular
Applicant
Ela Medical, Inc. 15245 Minnetonka Blvd., Minnetonka MN
Third party review
No

Clearances, product code DTB

Trailing 12 months

FDA records hold no clearances under product code DTB in the trailing twelve months.

FDA records show no clearances under product code DTB in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DTB, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260