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FDA 510(k)

NEPHROSTOMY GUIDEWIRE SHEATH

K-Number: K845047 · 1985-01-15

ApplicantAmerican Edwards Laboratories
Decision Date1985-01-15
Product CodeLJE
DecisionSubstantially Equivalent

Device Summary

NEPHROSTOMY GUIDEWIRE SHEATH is the device name listed in this FDA 510(k) record. The listed applicant is American Edwards Laboratories. It received FDA 510(k) clearance on 1985-01-15 under 510(k) number K845047. The device is classified under product code LJE. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEPHROSTOMY GUIDEWIRE SHEATH?

NEPHROSTOMY GUIDEWIRE SHEATH is a medical device that received FDA 510(k) clearance on 1985-01-15. The listed applicant is American Edwards Laboratories. The 510(k) number is K845047.

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

NEPHROSTOMY GUIDEWIRE SHEATH received FDA 510(k) clearance on 1985-01-15, under 510(k) number K845047.

Who is the listed applicant for NEPHROSTOMY GUIDEWIRE SHEATH?

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

What is the FDA product code for NEPHROSTOMY GUIDEWIRE SHEATH?

The FDA product code for NEPHROSTOMY GUIDEWIRE SHEATH is LJE.

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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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