STELA UT46 AND BT45/46 STRAIGHT TINED PACING LEADS, STELA UJ45 AND BJ44/45 J-SHAPED TINED PACING LEADS— 510(k) K993448

Name: FDA 510(k) clearance K993448
Creator: U.S. Food and Drug Administration
Published: 2000-04-10

Substantially Equivalent - Subject to Tracking Reg.

Ela Medical, Inc.

FDA 510(k) clearance K993448 for STELA UT46 AND BT45/46 STRAIGHT TINED PACING LEADS, STELA UJ45 AND BJ44/45 J-SHAPED TINED PACING LEADS, Substantially Equivalent - Subject to Tracking Reg. on 2000-04-10. Applicant: Ela Medical, Inc.. Device class: 3.

Clearance details

Applicant: Ela Medical, Inc.
Product code: Code DTB
Device class: Class 3
Regulation: 21 CFR 870.3680
Advisory panel: Cardiovascular
Date received: 1999-10-12
Decision date: 2000-04-10
Decision: Substantially Equivalent - Subject to Tracking Reg.
Clearance type: Traditional
Location: Plymouth, MN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DTB

view all

K061212 — BIOTRONIK ENDOCARDIAL PACING LEADS2006-07-10
K041809 — PERMANENT PACING LEAD, MODEL PY22004-08-06
K040569 — PERMANENT PACING LEAD, MODEL REFINO, MODEL: REFINO-R, RU, RJU2004-04-07
K031274 — MODEL 5071 MYOCARDIAL PACING LEAD2003-05-22
K031210 — MODEL 4951M MYOCARDIAL UNIPOLAR LEAD2003-05-16

More clearances from Ela Medical, Inc.

view all

K042002 — SYNESCOPE, EASYSCOPE, SYNECOM, HOLTERREADER2004-10-20
K032466 — SPIDERVIEW2003-08-22
K002817 — SYNETEC2001-05-02
K000029 — STELA UT46 AND BT45/46 STRAIGHT TINED PACING LEADS, STELA UJ45 AND BJ44/45 J-SHAPED TINED PACING LEADS2000-04-04
K990727 — SYNEFLASH & SYNEVIEW1999-11-26

Adverse events under product code DTB

product code DTB

Death: 1,491
Injury: 67,311
Malfunction: 79,368
Other: 10
Total: 148,180

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.