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FDA 510(k)

POLARIS X CATHETERS, MODEL 7000D,7001D,7003D,7004D,7005D,7006D

K-Number: K003452 · 2000-12-07

ApplicantEp Technologies, Inc.
Decision Date2000-12-07
Product CodeDRF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

POLARIS X CATHETERS, MODEL 7000D,7001D,7003D,7004D,7005D,7006D 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 2000-12-07 under 510(k) number K003452. 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 POLARIS X CATHETERS, MODEL 7000D,7001D,7003D,7004D,7005D,7006D?

POLARIS X CATHETERS, MODEL 7000D,7001D,7003D,7004D,7005D,7006D is a medical device that received FDA 510(k) clearance on 2000-12-07. The listed applicant is Ep Technologies, Inc.. The 510(k) number is K003452.

When did POLARIS X CATHETERS, MODEL 7000D,7001D,7003D,7004D,7005D,7006D receive FDA 510(k) clearance?

POLARIS X CATHETERS, MODEL 7000D,7001D,7003D,7004D,7005D,7006D received FDA 510(k) clearance on 2000-12-07, under 510(k) number K003452.

Who is the listed applicant for POLARIS X CATHETERS, MODEL 7000D,7001D,7003D,7004D,7005D,7006D?

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 POLARIS X CATHETERS, MODEL 7000D,7001D,7003D,7004D,7005D,7006D?

The FDA product code for POLARIS X CATHETERS, MODEL 7000D,7001D,7003D,7004D,7005D,7006D 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 SYSTEMK940167DIAGNOSTIC I CATHETERK940168DIAGNOSTIC II CATHETERK924108TRACFINDER IIK924109STEEROCATH 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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