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FDA 510(k)

HYDROPHILIC COATED GUIDEWIRE

K-Number: K981667 · 1998-06-05

ApplicantLake Region Mfg., Inc.
Decision Date1998-06-05
Product CodeKNY
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

HYDROPHILIC COATED GUIDEWIRE is the device name listed in this FDA 510(k) record. The listed applicant is Lake Region Mfg., Inc.. It received FDA 510(k) clearance on 1998-06-05 under 510(k) number K981667. 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 HYDROPHILIC COATED GUIDEWIRE?

HYDROPHILIC COATED GUIDEWIRE is a medical device that received FDA 510(k) clearance on 1998-06-05. The listed applicant is Lake Region Mfg., Inc.. The 510(k) number is K981667.

When did HYDROPHILIC COATED GUIDEWIRE receive FDA 510(k) clearance?

HYDROPHILIC COATED GUIDEWIRE received FDA 510(k) clearance on 1998-06-05, under 510(k) number K981667.

Who is the listed applicant for HYDROPHILIC COATED GUIDEWIRE?

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

What is the FDA product code for HYDROPHILIC COATED GUIDEWIRE?

The FDA product code for HYDROPHILIC COATED GUIDEWIRE is KNY.

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Other records listing Lake Region Mfg., 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.

K092965TRAILRUNNER GUIDEWIRESK082922FREEWAY AND RAILRUNNER GUIDEWIRESK081708TAXI ENDOSCOPIC GUIDEWIREK080144MANDREL GUIDEWIRES OR M-WIRESK073655PEGASUS STEERABLE (PTCA) GUIDEWIREK060454TITAN GUIDEWIRE

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Related Devices (Code: KNY)

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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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