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FDA 510(k)

GUIDE-TECH ENCAPSULATED GUIDEWIRE

K-Number: K926039 · 1993-08-05

ApplicantCape Tech Medical Products
Decision Date1993-08-05
Product CodeKNY
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

GUIDE-TECH ENCAPSULATED GUIDEWIRE is the device name listed in this FDA 510(k) record. The listed applicant is Cape Tech Medical Products. It received FDA 510(k) clearance on 1993-08-05 under 510(k) number K926039. The device is classified under product code KNY. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GUIDE-TECH ENCAPSULATED GUIDEWIRE?

GUIDE-TECH ENCAPSULATED GUIDEWIRE is a medical device that received FDA 510(k) clearance on 1993-08-05. The listed applicant is Cape Tech Medical Products. The 510(k) number is K926039.

When did GUIDE-TECH ENCAPSULATED GUIDEWIRE receive FDA 510(k) clearance?

GUIDE-TECH ENCAPSULATED GUIDEWIRE received FDA 510(k) clearance on 1993-08-05, under 510(k) number K926039.

Who is the listed applicant for GUIDE-TECH ENCAPSULATED GUIDEWIRE?

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

What is the FDA product code for GUIDE-TECH ENCAPSULATED GUIDEWIRE?

The FDA product code for GUIDE-TECH ENCAPSULATED GUIDEWIRE is KNY.

Related Clinical Trials

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 Cape Tech Medical Products 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.

K926038FLEX-TECH BALLOON DILATORK926040HELI-TECH RETRIEVAL BASKET

Related Devices (Code: KNY)

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.

K260919Transurethral Catheter Safety Valve (TUCSV) (80050)Class Medical , Ltd.K182144Bi-Flex EvoPromepla SamK162356Vesair Cystoscopic SheathSolace TherapeuticsK131803GUARDIAN URETHRAL SHEATHSolace TherapeuticsK123170VARI-PASS VARIABLE LENGTH ACCESS SHEATHOlympus Surgical Technologies AmericaK120160ROCAMED ROCAUS PLATINUMPromepla Sam

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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