ELA MEDICAL PACING LEADS PMC 860 PMCF 860 PBCF860— 510(k) K851731
Substantially EquivalentEla Medical, Inc.
FDA 510(k) clearance K851731 for ELA MEDICAL PACING LEADS PMC 860 PMCF 860 PBCF860, Substantially Equivalent on 1985-08-29. 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.