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FDA 510(k)

STEEROCATH(TM)

K-Number: K900765 · 1990-05-07

ApplicantEp Technologies, Inc.
Decision Date1990-05-07
Product CodeDRF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

STEEROCATH(TM) is the device name listed in this FDA 510(k) record. The listed applicant is Ep Technologies, Inc.. It received FDA 510(k) clearance on 1990-05-07 under 510(k) number K900765. 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 STEEROCATH(TM)?

STEEROCATH(TM) is a medical device that received FDA 510(k) clearance on 1990-05-07. The listed applicant is Ep Technologies, Inc.. The 510(k) number is K900765.

When did STEEROCATH(TM) receive FDA 510(k) clearance?

STEEROCATH(TM) received FDA 510(k) clearance on 1990-05-07, under 510(k) number K900765.

Who is the listed applicant for STEEROCATH(TM)?

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

What is the FDA product code for STEEROCATH(TM)?

The FDA product code for STEEROCATH(TM) is DRF.

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Other records listing Ep Technologies, Inc. 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.

K043257REAL-TIME POSITION MANAGEMENT (RPM) SYSTEMK013349ASTRONOMER PLUS SYSTEMK003452POLARIS X CATHETERS, MODEL 7000D,7001D,7003D,7004D,7005D,7006DK940167DIAGNOSTIC I CATHETERK940168DIAGNOSTIC II CATHETERK924109STEEROCATH II

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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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