SYNETEC— 510(k) K002817
Substantially EquivalentEla Medical, Inc.
FDA 510(k) clearance K002817 for SYNETEC, Substantially Equivalent on 2001-05-02. Applicant: Ela Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Ela Medical, Inc.
- Product code
- Code DQK
- Device class
- Class 2
- Regulation
- 21 CFR 870.1425
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Plymouth, MN, US
Recent devices under product code DQK
view allMore clearances from Ela Medical, Inc.
view all- K042002 — SYNESCOPE, EASYSCOPE, SYNECOM, HOLTERREADER
- K032466 — SPIDERVIEW
- 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
- K990727 — SYNEFLASH & SYNEVIEW
Adverse events under product code DQK
product code DQK- Death
- 10
- Injury
- 225
- Malfunction
- 2,123
- Other
- 2
- Total
- 2,360
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.