PENTARAY NAV HIGH-DENSITY MAPPING CATHETER— 510(k) K120425
Substantially EquivalentBiosense Webster, Inc.
FDA 510(k) clearance K120425 for PENTARAY NAV HIGH-DENSITY MAPPING CATHETER, Substantially Equivalent on 2012-05-24. Applicant: Biosense Webster, Inc.. Device class: 2.
Clearance details
- Applicant
- Biosense Webster, Inc.
- 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
- Traditional
- Location
- Diamond Bar, CA, US
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- 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 Biosense Webster, Inc.
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 →
Recalls naming K120425
K-number listed on FDA's recall record- Z-2371-2020 — PENTARAY NAV HIGH-DENSITY MAPPING CATHETER ELECTRODE EA 22 Rx only STERILE EO - Product Usage: The Biosense Webster PENTARAY NAV High-Density Mapping Catheter is indicated for multiple electrode electrophysiological mapping of cardiac structures in the heart, i.e., recording or stimulation only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart.
- Z-0211-2018 — PENTARAY NAV High-Density Mapping Catheter.
- Z-0212-2018 — PENTARAY NAV High-Density Mapping Catheter.
- Z-1590-2016 — Pentaray NAV High-Density Mapping Catheter, Catalog No. D128201, D128202, D128203, D128204, D128205, D128206 The Biosense Webster Pentaray NAV High-Density Mapping Catheter is intended for multiple electrode electrophysiological mapping of cardiac structures in the heart, ie., recording or stimulation only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart. The Pentaray NAV High-Density Mapping Catheter provides location information when used with compatible CARTO 3 EP Navigation Systems.
- Z-1176-2014 — PENTARAY NAV High-Density Mapping Catheter and PENTARAY NAV ECO Catheter, Catalog No. D128201, D128202, D128204, D128205, D128207, D128208, D128210, D128211. The Biosense Webster PENTARAY NAV High-Density Mapping Catheter is indicated for multiple electrode electrophysiological mapping of cardiac structures in the heart, i.e., recording or stimulation only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K120425.
Data sourced from openFDA. This site is unofficial and independent of the FDA.