FDA 510(k)

IntellaMap Orion High Resolution Mapping Catheter

K-Number: K220796 · 2022-06-10

Decision Date2022-06-10

Product CodeDRF

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

IntellaMap Orion High Resolution Mapping Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corporation. It received FDA 510(k) clearance on 2022-06-10 under 510(k) number K220796. The device is classified under product code DRF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IntellaMap Orion High Resolution Mapping Catheter?

IntellaMap Orion High Resolution Mapping Catheter is a medical device that received FDA 510(k) clearance on 2022-06-10. The listed applicant is Boston Scientific Corporation. The 510(k) number is K220796.

When did IntellaMap Orion High Resolution Mapping Catheter receive FDA 510(k) clearance?

IntellaMap Orion High Resolution Mapping Catheter received FDA 510(k) clearance on 2022-06-10, under 510(k) number K220796.

Who is the listed applicant for IntellaMap Orion High Resolution Mapping Catheter?

The FDA 510(k) record lists Boston Scientific Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IntellaMap Orion High Resolution Mapping Catheter?

The FDA product code for IntellaMap Orion High Resolution Mapping Catheter is DRF.

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Related Devices (Code: DRF)

K252794Vision-MR™ Diagnostic CatheterImricor Medical Systems, Inc.K250590MAGiC Sweep™ EP Mapping CatheterStereotaxis, Inc.K250310VIKING™ Fixed Curve Diagnostic CatheterBoston Scientific Corporation PMA P990025CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDINGBiosense Webster, Inc.K240366EP•XT™ Unidirectional Steerable Diagnostic Catheter; Dynamic Tip™ Unidirectional Steerable Diagnostic Catheter; Dynamic XT™ Unidirectional Steerable Diagnostic CatheterBoston Scientific Corporation K233900Nordica PV Cryo Mapping CatheterSynaptic Medical Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.