Flower High-Density Mapping Catheter, 4-4-4 MM Electrode Spacing), (2-6-2 MM Electrode Spacing)
FDA 510(k) K050217 · Biosense Webster, Inc.
510(k) numberK050217
Submission
- Device name
- Flower High-Density Mapping Catheter, 4-4-4 MM Electrode Spacing), (2-6-2 MM Electrode Spacing)
- Applicant
- Biosense Webster, Inc.
Diamond Bar, CA, US - Received
- January 31, 2005
- Decision date
- March 30, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MTD – Catheter, Intracardiac Mapping, High-Density Array
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1220
- Specialty
- Cardiovascular
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| K253205 | OptiMap Catheter - 50mm (OPTI-CATH2-50)MTD · Traditional | Cortex, Inc. | 03/13/2026SE |
| K233433 | Sphere-9Dx Diagnostic Catheter (AFR-00009)MTD · Traditional | Medtronic | 08/07/2024SE |
| K241372 | Advisor HD Grid X Mapping Catheter, Sensor EnabledMTD · Special | Abbott Medical | 07/09/2024SE |
| K231312 | PENTARAY® NAV ECO High Density Mapping Catheter, DECANAV® Mapping Catheter, Webster® CS…MTD · Special | Biosense Webster, Inc. | 07/10/2023SE |
| K223666 | Ablacath Mapping CatheterMTD · Traditional | Ablacon, Inc. | 03/17/2023SE |
| K230253 | OPTRELL Mapping Catheter with TRUEref TechnologyMTD · Special | Biosense Webster, Inc. | 03/02/2023SE |
| K210766 | AcQMap 3D Imaging and Mapping Catheter, Model 900009MTD · Traditional | Acutus Medical, Inc. | 06/21/2022SE |
| K211438 | OPTRELL Mapping Catheter with TRUEref TechnologyMTD · Traditional | Biosense Webster, Inc. | 03/18/2022SE |
| K201806 | Reprocessed PentaRay Nav eco High-Density Mapping CatheterMTD · Traditional | Sterilmed Inc. (Johnson and Johnson) | 06/23/2021SE |
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| K231312 | PENTARAY® NAV ECO High Density Mapping Catheter, DECANAV® Mapping Catheter, Webster® CS…MTD · Special | 07/10/2023SE |
| K230253 | OPTRELL Mapping Catheter with TRUEref TechnologyMTD · Special | 03/02/2023SE |
| K223766 | NUVISION NAV Ultrasound CatheterOBJ · Traditional | 02/16/2023SE |
Questions and answers
When was Flower High-Density Mapping Catheter, 4-4-4 MM Electrode Spacing), (2-6-2 MM Electrode Spacing) cleared by the FDA?
Flower High-Density Mapping Catheter, 4-4-4 MM Electrode Spacing), (2-6-2 MM Electrode Spacing) (K050217) received a 510(k) decision of Substantially Equivalent on March 30, 2005, 58 days after the submission was received.
What is the product code of K050217?
The FDA product code is MTD – Catheter, Intracardiac Mapping, High-Density Array, a Class II (moderate risk) device regulated under 21 CFR 870.1220.