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FDA 510(k)

ENDOCATH ELECTROPHYSIOLOGY CATHETER

K-Number: K926549 · 1993-12-06

ApplicantEndo-Therapeutics, Inc.
Decision Date1993-12-06
Product CodeDRF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ENDOCATH ELECTROPHYSIOLOGY CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Endo-Therapeutics, Inc.. It received FDA 510(k) clearance on 1993-12-06 under 510(k) number K926549. 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 ENDOCATH ELECTROPHYSIOLOGY CATHETER?

ENDOCATH ELECTROPHYSIOLOGY CATHETER is a medical device that received FDA 510(k) clearance on 1993-12-06. The listed applicant is Endo-Therapeutics, Inc.. The 510(k) number is K926549.

When did ENDOCATH ELECTROPHYSIOLOGY CATHETER receive FDA 510(k) clearance?

ENDOCATH ELECTROPHYSIOLOGY CATHETER received FDA 510(k) clearance on 1993-12-06, under 510(k) number K926549.

Who is the listed applicant for ENDOCATH ELECTROPHYSIOLOGY CATHETER?

The FDA 510(k) record lists Endo-Therapeutics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ENDOCATH ELECTROPHYSIOLOGY CATHETER?

The FDA product code for ENDOCATH ELECTROPHYSIOLOGY CATHETER is DRF.

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Other records listing Endo-Therapeutics, Inc. as applicant

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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 CorporationK240366EP•XT™ Unidirectional Steerable Diagnostic Catheter; Dynamic Tip™ Unidirectional Steerable Diagnostic Catheter; Dynamic XT™ Unidirectional Steerable Diagnostic CatheterBoston Scientific CorporationK233900Nordica PV Cryo Mapping CatheterSynaptic Medical CorporationK233397Cosine-10TM Diagnostic CatheterMedtronic, Inc.

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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