PACEMAKER LEAD ADAPTER— 510(k) K890018
Substantially EquivalentEla Medical, Inc.
FDA 510(k) clearance K890018 for PACEMAKER LEAD ADAPTER, Substantially Equivalent on 1989-06-20. 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
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Minnetonka, MN, US
Recent devices under product code DTB
view allMore clearances from Ela Medical, Inc.
view all- K042002 — SYNESCOPE, EASYSCOPE, SYNECOM, HOLTERREADER
- K032466 — SPIDERVIEW
- K002817 — SYNETEC
- K993448 — STELA UT46 AND BT45/46 STRAIGHT TINED PACING LEADS, STELA UJ45 AND BJ44/45 J-SHAPED TINED PACING LEADS
- K000029 — STELA UT46 AND BT45/46 STRAIGHT TINED PACING LEADS, STELA UJ45 AND BJ44/45 J-SHAPED TINED PACING LEADS
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, through . 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.