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FDA 510(k)

FLEXFINDER GUIDE WIRE(REGULAR SHAFT/STIFF SHAFT) MARKED INK BANDS, FLEXFINDER GUIDE WIRE (REGULAR SHAFT/STIFF SHAFT) NO

K-Number: K990765 · 1999-03-15

ApplicantFlexmedics
Decision Date1999-03-15
Product CodeOCY
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FLEXFINDER GUIDE WIRE(REGULAR SHAFT/STIFF SHAFT) MARKED INK BANDS, FLEXFINDER GUIDE WIRE (REGULAR SHAFT/STIFF SHAFT) NO is the device name listed in this FDA 510(k) record. The listed applicant is Flexmedics. It received FDA 510(k) clearance on 1999-03-15 under 510(k) number K990765. The device is classified under product code OCY. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLEXFINDER GUIDE WIRE(REGULAR SHAFT/STIFF SHAFT) MARKED INK BANDS, FLEXFINDER GUIDE WIRE (REGULAR SHAFT/STIFF SHAFT) NO?

FLEXFINDER GUIDE WIRE(REGULAR SHAFT/STIFF SHAFT) MARKED INK BANDS, FLEXFINDER GUIDE WIRE (REGULAR SHAFT/STIFF SHAFT) NO is a medical device that received FDA 510(k) clearance on 1999-03-15. The listed applicant is Flexmedics. The 510(k) number is K990765.

When did FLEXFINDER GUIDE WIRE(REGULAR SHAFT/STIFF SHAFT) MARKED INK BANDS, FLEXFINDER GUIDE WIRE (REGULAR SHAFT/STIFF SHAFT) NO receive FDA 510(k) clearance?

FLEXFINDER GUIDE WIRE(REGULAR SHAFT/STIFF SHAFT) MARKED INK BANDS, FLEXFINDER GUIDE WIRE (REGULAR SHAFT/STIFF SHAFT) NO received FDA 510(k) clearance on 1999-03-15, under 510(k) number K990765.

Who is the listed applicant for FLEXFINDER GUIDE WIRE(REGULAR SHAFT/STIFF SHAFT) MARKED INK BANDS, FLEXFINDER GUIDE WIRE (REGULAR SHAFT/STIFF SHAFT) NO?

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

What is the FDA product code for FLEXFINDER GUIDE WIRE(REGULAR SHAFT/STIFF SHAFT) MARKED INK BANDS, FLEXFINDER GUIDE WIRE (REGULAR SHAFT/STIFF SHAFT) NO?

The FDA product code for FLEXFINDER GUIDE WIRE(REGULAR SHAFT/STIFF SHAFT) MARKED INK BANDS, FLEXFINDER GUIDE WIRE (REGULAR SHAFT/STIFF SHAFT) NO is OCY.

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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.

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Other records listing Flexmedics 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.

K964955FLEXFINDER GUIDEWIRE (REGULAR SHAFT/STIFF SHAFT) MARKED INK BANDS ENCAP+/GUIDEWIRE(REGULAR SHAFT/STIFF SHAFT) NO MARKINGK952430FINESSE GUIDEWIRE CORONARYK943390FLEXFINDER GUIDEWIREK942074FLEXFINDER GUIDEWIREK934265FLEXMEDICS SUPER-SEVEN STRANDED NICKEL-TITANIUM ARCHWIREK912843FLEXMEDICS RETRACT ORTH PROBE, PETTINE BONE PROBE

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Related Devices (Code: OCY)

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.

K153264EasyPass GuidewireMedi-Globe CorporationK131072ORCHESTRA HYDROPHILIC GUIDEWIRE STANDARD ANGLED, ORCHESTRA HYDROPHILIC GUIDEWIRE STRAIGHT STIFF, ORCHESTRA HYDROPHILICColoplast A/SK124052OSTAVI HYDROPHILIC GUIDEWIRELake Region MedicalK123438XENX STONE MANAGEMENT DEVICEXenolith MedicalK123439NEO ERCP GUIDEWIRENeometrics, Inc.K122816AXCESS SOFT TIP WIRE GUIDEWilson-Cook Medical, 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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