LASSO 2515 NAV ECO VARIABLE CATHETER LASSO NAV ECO CATHETER CONTINUED FROM LINE 2— 510(k) K113213
Substantially EquivalentBiosense Webster, Inc.
FDA 510(k) clearance K113213 for LASSO 2515 NAV ECO VARIABLE CATHETER LASSO NAV ECO CATHETER CONTINUED FROM LINE 2, Substantially Equivalent on 2011-12-05. Applicant: Biosense Webster, Inc.. Device class: 2.
Clearance details
- Applicant
- Biosense Webster, Inc.
- Product code
- Code DRF
- Device class
- Class 2
- Regulation
- 21 CFR 870.1220
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Diamond Bar, CA, US
Recent devices under product code DRF
view allMore clearances from Biosense Webster, Inc.
view allAdverse events under product code DRF
product code DRF- Death
- 127
- Injury
- 1,676
- Malfunction
- 2,003
- Other
- 1
- Total
- 3,807
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 →
Recalls naming K113213
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K113213.
Data sourced from openFDA. This site is unofficial and independent of the FDA.