ENSITE ARRAY MULTI-ELECTRODE DIAGNOSTIC CATHETER— 510(k) K121006
Substantially EquivalentSt Jude Medical
FDA 510(k) clearance K121006 for ENSITE ARRAY MULTI-ELECTRODE DIAGNOSTIC CATHETER, Substantially Equivalent on 2012-05-03. Applicant: St Jude Medical. Device class: 2.
Clearance details
- Applicant
- St Jude Medical
- Product code
- Code MTD
- Device class
- Class 2
- Regulation
- 21 CFR 870.1220
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Minnetonka, MN, US
Recent devices under product code MTD
view all- K261012 — OptiMap Catheter - 60mm (OPTI-CATH2-60)
- K253205 — OptiMap Catheter - 50mm (OPTI-CATH2-50)
- K233433 — Sphere-9Dx Diagnostic Catheter (AFR-00009)
- K241372 — Advisor HD Grid X Mapping Catheter, Sensor Enabled
- K231312 — PENTARAY® NAV ECO High Density Mapping Catheter, DECANAV® Mapping Catheter, Webster® CS Catheter with Auto ID, Webster® CS Catheter with EZ Steer Technology, Webster® CS Catheter with EZ Steer Technology with Auto ID
More clearances from St Jude Medical
view allAdverse events under product code MTD
product code MTD- Death
- 22
- Injury
- 376
- Malfunction
- 986
- Total
- 1,384
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.