EnSite Velocity Cardiac Mapping System v5.2— 510(k) K172396
Substantially EquivalentSt Jude Medical
FDA 510(k) clearance K172396 for EnSite Velocity Cardiac Mapping System v5.2, Substantially Equivalent on 2018-04-23. Applicant: St Jude Medical. Device class: 2.
Clearance details
- Applicant
- St Jude Medical
- 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
- St. Paul, MN, US
Recent devices under product code DQK
view allMore clearances from St Jude Medical
view all- K181382 — GuardianTM Burr Hole Cover System
- K173232 — myMerlin(TM) Mobile Application Model APP1001
- K160210 — EnSite Precision Cardiac Mapping System v2.0
- K160218 — AutoMark Module
- K160335 — Advisor FL 15mm 12 Pole 333 Uni D, Advisor FL 20mm 12 Pole 555 Uni D, Advisor FL 15mm 12 Pole 333 Bi D, Advisor FL 20mm 12 Pole 555 Bi D
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.