Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled— 510(k) K200212
Substantially EquivalentInnovative Health, LLC
FDA 510(k) clearance K200212 for Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled, Substantially Equivalent on 2020-09-03. Applicant: Innovative Health, LLC. Device class: 2.
Clearance details
- Applicant
- Innovative Health, LLC
- 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
- Scottsdale, AZ, 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 Innovative Health, LLC
view all- K231015 — Reprocessed Super Torque and Super Torque Plus Diagnostic Angiographic Catheters
- K232037 — Reprocessed VersaCross Steerable Sheath; Reprocessed SureFlex Steerable Guiding Sheath
- K230376 — Reprocessed Agilis NxT Steerable Introducer
- K213584 — Reprocessed NRG Transseptal Needle
- K221854 — Reprocesses Umbilical Cable
Adverse 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.