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FDA 510(k)

Reprocessed Inquiry Steerable Diagnostic EP Catheter

K-Number: K203261 · 2021-03-05

ApplicantInnovative Health, LLC
Decision Date2021-03-05
Product CodeDRF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Reprocessed Inquiry Steerable Diagnostic EP Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Innovative Health, LLC. It received FDA 510(k) clearance on 2021-03-05 under 510(k) number K203261. 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 Reprocessed Inquiry Steerable Diagnostic EP Catheter?

Reprocessed Inquiry Steerable Diagnostic EP Catheter is a medical device that received FDA 510(k) clearance on 2021-03-05. The listed applicant is Innovative Health, LLC. The 510(k) number is K203261.

When did Reprocessed Inquiry Steerable Diagnostic EP Catheter receive FDA 510(k) clearance?

Reprocessed Inquiry Steerable Diagnostic EP Catheter received FDA 510(k) clearance on 2021-03-05, under 510(k) number K203261.

Who is the listed applicant for Reprocessed Inquiry Steerable Diagnostic EP Catheter?

The FDA 510(k) record lists Innovative Health, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Reprocessed Inquiry Steerable Diagnostic EP Catheter?

The FDA product code for Reprocessed Inquiry Steerable Diagnostic EP Catheter is DRF.

Other records listing Innovative Health, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250305Reprocessed Agilis NxT Steerable IntroducerK231015Reprocessed Super Torque and Super Torque Plus Diagnostic Angiographic CathetersK233825Reprocessed Webster Duo-Decapolar Diagnostic EP CatheterK232037Reprocessed VersaCross Steerable Sheath; Reprocessed SureFlex Steerable Guiding SheathK230376Reprocessed Agilis NxT Steerable IntroducerK213584Reprocessed NRG Transseptal Needle

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Related Devices (Code: DRF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252794Vision-MR™ Diagnostic CatheterImricor Medical Systems, Inc.K250590MAGiC Sweep™ EP Mapping CatheterStereotaxis, Inc.K250310VIKING™ Fixed Curve Diagnostic CatheterBoston Scientific CorporationPMA 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 CorporationK233900Nordica 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.

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