Submission Details
| 510(k) Number | K233433 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 12, 2023 |
| Decision Date | August 07, 2024 |
| Days to Decision | 300 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
Sphere-9Dx Diagnostic Catheter (AFR-00009)
Aug 2024
Decision
300d
Days
Class 2
Risk
About This 510(k) Submission
K233433 is an FDA 510(k) clearance for the Sphere-9Dx Diagnostic Catheter (AFR-00009), a Catheter, Intracardiac Mapping, High-density Array (Class II — Special Controls, product code MTD), submitted by Medtronic (Mounds View, US). The FDA issued a Cleared decision on August 7, 2024, 300 days after receiving the submission on October 12, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1220.
Device Classification
| Product Code | MTD — Catheter, Intracardiac Mapping, High-density Array |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.1220 |
Manufacturer
Similar Devices — MTD Catheter, Intracardiac Mapping, High-density Array
All 32
K253205 · Cortex, Inc.
· Mar 2026
K241372 · Abbott Medical
· Jul 2024
K231312 · Biosense Webster, Inc.
· Jul 2023
K223666 · Ablacon, Inc.
· Mar 2023
K230253 · Biosense Webster, Inc.
· Mar 2023
K210766 · Acutus Medical, Inc.
· Jun 2022
More from Medtronic
View all
K251744
· DTM · Jan 2026
K240190
· DTR · Feb 2024
K223494
· NKB · Jan 2023
K223178
· DQY · Nov 2022
K222873
· DQY · Nov 2022