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FDA 510(k)

FRANZ(TM) MOVEABLE STYLET MAP CATHETER, MODIFIED

K-Number: K892207 · 1989-06-12

ApplicantEp Technologies, Inc.
Decision Date1989-06-12
Product CodeDRF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FRANZ(TM) MOVEABLE STYLET MAP CATHETER, MODIFIED 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 1989-06-12 under 510(k) number K892207. 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 FRANZ(TM) MOVEABLE STYLET MAP CATHETER, MODIFIED?

FRANZ(TM) MOVEABLE STYLET MAP CATHETER, MODIFIED is a medical device that received FDA 510(k) clearance on 1989-06-12. The listed applicant is Ep Technologies, Inc.. The 510(k) number is K892207.

When did FRANZ(TM) MOVEABLE STYLET MAP CATHETER, MODIFIED receive FDA 510(k) clearance?

FRANZ(TM) MOVEABLE STYLET MAP CATHETER, MODIFIED received FDA 510(k) clearance on 1989-06-12, under 510(k) number K892207.

Who is the listed applicant for FRANZ(TM) MOVEABLE STYLET MAP CATHETER, MODIFIED?

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 FRANZ(TM) MOVEABLE STYLET MAP CATHETER, MODIFIED?

The FDA product code for FRANZ(TM) MOVEABLE STYLET MAP CATHETER, MODIFIED 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 CATHETERK924108TRACFINDER 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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