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FDA 510(k)

EDSLAB CATHETER COVER

K-Number: K813514 · 1981-12-29

ApplicantAmerican Edwards Laboratories
Decision Date1981-12-29
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EDSLAB CATHETER COVER 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 1981-12-29 under 510(k) number K813514. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EDSLAB CATHETER COVER?

EDSLAB CATHETER COVER is a medical device that received FDA 510(k) clearance on 1981-12-29. The listed applicant is American Edwards Laboratories. The 510(k) number is K813514.

When did EDSLAB CATHETER COVER receive FDA 510(k) clearance?

EDSLAB CATHETER COVER received FDA 510(k) clearance on 1981-12-29, under 510(k) number K813514.

Who is the listed applicant for EDSLAB CATHETER COVER?

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 EDSLAB CATHETER COVER?

The FDA product code for EDSLAB CATHETER COVER is DQY.

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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: DQY)

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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