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FDA 510(k)

DILATOR/SHEATH SET

K-Number: K842632 · 1984-10-02

ApplicantAmerican Edwards Laboratories
Decision Date1984-10-02
Product CodeEZN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DILATOR/SHEATH SET 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 1984-10-02 under 510(k) number K842632. The device is classified under product code EZN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DILATOR/SHEATH SET?

DILATOR/SHEATH SET is a medical device that received FDA 510(k) clearance on 1984-10-02. The listed applicant is American Edwards Laboratories. The 510(k) number is K842632.

When did DILATOR/SHEATH SET receive FDA 510(k) clearance?

DILATOR/SHEATH SET received FDA 510(k) clearance on 1984-10-02, under 510(k) number K842632.

Who is the listed applicant for DILATOR/SHEATH SET?

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 DILATOR/SHEATH SET?

The FDA product code for DILATOR/SHEATH SET is EZN.

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Other records listing American Edwards Laboratories 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.

K873485EDSLAB (R) OCCLUSION BALLOON CATHETERK872596TRANTEC DISPOSABLE PRESSURE TRANS.53-600/F/F30K872529THERMODILUTION CARDIAC OUTPUT COMPUTER, MOD. COM-2K870444HOMEPRO II VOLUMETRIC INFUSION PUMPK864997MEDTRAC VP VOLUMETRIC INFUSION PUMPK864330SHEAR FORCE GAUGE

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Related Devices (Code: EZN)

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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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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