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FDA 510(k)

SOFT, SPRING TIPPED NYLON COATED GUIDE WIRE

K-Number: K901429 · 1990-06-05

ApplicantTelemed Systems, Inc.
Decision Date1990-06-05
Product CodeOCY
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SOFT, SPRING TIPPED NYLON COATED GUIDE WIRE is the device name listed in this FDA 510(k) record. The listed applicant is Telemed Systems, Inc.. It received FDA 510(k) clearance on 1990-06-05 under 510(k) number K901429. 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 SOFT, SPRING TIPPED NYLON COATED GUIDE WIRE?

SOFT, SPRING TIPPED NYLON COATED GUIDE WIRE is a medical device that received FDA 510(k) clearance on 1990-06-05. The listed applicant is Telemed Systems, Inc.. The 510(k) number is K901429.

When did SOFT, SPRING TIPPED NYLON COATED GUIDE WIRE receive FDA 510(k) clearance?

SOFT, SPRING TIPPED NYLON COATED GUIDE WIRE received FDA 510(k) clearance on 1990-06-05, under 510(k) number K901429.

Who is the listed applicant for SOFT, SPRING TIPPED NYLON COATED GUIDE WIRE?

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

What is the FDA product code for SOFT, SPRING TIPPED NYLON COATED GUIDE WIRE?

The FDA product code for SOFT, SPRING TIPPED NYLON COATED GUIDE WIRE is OCY.

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Other records listing Telemed Systems, Inc. as applicant

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K020379PPD BALLOON DILATATION CATHETERK013737MODIFICATION TO: 3-LUMEN DURALON OCCLUSION BALLOONK010412FLEXIBLE ENDOSCOPIC SCISSORSK9924025.0 FRENCH X 200CM X 35MM TIP TAPER-20MM CUTTING WIRE, 5.0 FRENCH X 200CM X 35MM TIP TAPER-30MM CUTTING WIRE, 5.0 FRENCHK992390HOT BIOPSY FORCEPS FEENESTRATED 230 CM OVAL CUP, HOT BIOPSY FORCEPS SERRATED 160 CM OVAL CUP, HOT BIOPSY FORCEPS SERRATDK974312REUSABLE BIOPSY FORCEPS OVAL CUP, REUSABLE BIOSY FORCEPS OVAL CUP W/NEEDLE, REUSABLE BIOPSY FORCEPS SERRATED CUP, REUSAR

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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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