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FDA 510(k)

ACUCISE GUIDEWIRE EXCHANGE SHEATH

K-Number: K941010 · 1994-04-18

ApplicantApplied Medical Resources
Decision Date1994-04-18
Product CodeEYB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ACUCISE GUIDEWIRE EXCHANGE SHEATH is the device name listed in this FDA 510(k) record. The listed applicant is Applied Medical Resources. It received FDA 510(k) clearance on 1994-04-18 under 510(k) number K941010. The device is classified under product code EYB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACUCISE GUIDEWIRE EXCHANGE SHEATH?

ACUCISE GUIDEWIRE EXCHANGE SHEATH is a medical device that received FDA 510(k) clearance on 1994-04-18. The listed applicant is Applied Medical Resources. The 510(k) number is K941010.

When did ACUCISE GUIDEWIRE EXCHANGE SHEATH receive FDA 510(k) clearance?

ACUCISE GUIDEWIRE EXCHANGE SHEATH received FDA 510(k) clearance on 1994-04-18, under 510(k) number K941010.

Who is the listed applicant for ACUCISE GUIDEWIRE EXCHANGE SHEATH?

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

What is the FDA product code for ACUCISE GUIDEWIRE EXCHANGE SHEATH?

The FDA product code for ACUCISE GUIDEWIRE EXCHANGE SHEATH is EYB.

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Related Devices (Code: EYB)

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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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