BIOSENSE WEBSTER PATIENT CABLE AND LEADWIRES— 510(k) K001390
Substantially EquivalentBiosense Webster, Inc.
FDA 510(k) clearance K001390 for BIOSENSE WEBSTER PATIENT CABLE AND LEADWIRES, Substantially Equivalent on 2000-07-21. Applicant: Biosense Webster, Inc.. Device class: 2.
Clearance details
- Applicant
- Biosense Webster, Inc.
- Product code
- Product code DSA
- Device class
- Class 2
- Regulation
- 21 CFR 870.2900
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Diamond Bar, CA, US
Recent devices under product code DSA
view allMore clearances from Biosense Webster, Inc.
view allAdverse events under product code DSA
product code DSA- Death
- 2
- Total
- 2
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.