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FDA 510(k)

HYPERFLEX FLEXIBLE GUIDEWIRES

K-Number: K941711 · 1994-08-26

ApplicantLinvatec Corp.
Decision Date1994-08-26
Product CodeLXH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

HYPERFLEX FLEXIBLE GUIDEWIRES is the device name listed in this FDA 510(k) record. The listed applicant is Linvatec Corp.. It received FDA 510(k) clearance on 1994-08-26 under 510(k) number K941711. The device is classified under product code LXH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HYPERFLEX FLEXIBLE GUIDEWIRES?

HYPERFLEX FLEXIBLE GUIDEWIRES is a medical device that received FDA 510(k) clearance on 1994-08-26. The listed applicant is Linvatec Corp.. The 510(k) number is K941711.

When did HYPERFLEX FLEXIBLE GUIDEWIRES receive FDA 510(k) clearance?

HYPERFLEX FLEXIBLE GUIDEWIRES received FDA 510(k) clearance on 1994-08-26, under 510(k) number K941711.

Who is the listed applicant for HYPERFLEX FLEXIBLE GUIDEWIRES?

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

What is the FDA product code for HYPERFLEX FLEXIBLE GUIDEWIRES?

The FDA product code for HYPERFLEX FLEXIBLE GUIDEWIRES is LXH.

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Other records listing Linvatec Corp. 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.

K092998CONMED LINVATEC INTERCEPT IMPLANTK091549CONMED LINVATEC SOFT TISSUE TO BONE SYSTEMK090835CONMED LINVATEC BIO MINI-REVO SUTURE ANCHOR, MODEL C6170CRK090186CONMED LINVATEC PALADIN, PRELOADED WITH TWO #2 HI-FI SUTURESK083281EL LIGHTWAVE SUCTION ABLATOR, MODEL EL-2000-S, LIGHTWAVE SUCTION ABLATOR, MODEL IA-2000-S, LIGHTWAVE ABLATOR, MODEL IA-K060198MICROPOWER HAND PIECE : MEDIUM SPEED DRILL, SAGGITAL SAW, RECIPROCATING SAW, AND OSCILLATING SAW

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Related Devices (Code: LXH)

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.

K192873SX-One MicroKnifeSonex Health, Inc.K101609SELF RETAINING SOFT TISSUE RETRACTORKoros USA, Inc.K001507MICROPERFORATION INSTRUMENTSmith & Nephew, Inc.K952495ANCHORS AWAY SOFT TISSUE ATTACHMENT SYSTEMOrthopedic Systems, Inc.K943873ORTHOMET ANATOMICALLY GUIDED CARPAL TUNNEL RELEASE SYOrthomet, Inc.K944188SPINAL MARKERLeibinger L.P.

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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